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Boston Scientific

United States·US-MF-000004702

Last updated September 17, 2026

What Boston Scientific makes

The company manufactures single-use vascular guide catheters and angiographic catheters for diagnostic and interventional procedures, including peripheral and coronary angioplasty balloon catheters. It also produces polymeric ureteral stents, nephrostomy catheters, and endovascular stents like the WALLSTENT® Endoprosthesis. Additional offerings include endoscopy preparation and cleaning kits, as well as devices for embolization and imaging guidance.

The portfolio includes devices classified under Class I, Class II, Class IIb, Class III, and Unclassified (U) categories, regulated through pathways such as the FDA’s 510(k) and Unique Device Identification (UDI) system. These products are also listed in the EU’s eudamed registry, reflecting their regulatory compliance in both US and European markets. The company operates with a US-based manufacturing presence.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Boston Scientific primarily manufacture?

Boston Scientific specializes in a range of interventional and diagnostic devices. Their portfolio includes single-use vascular guide catheters and angiographic catheters, which are used for guiding and imaging during procedures like angioplasty. They also produce peripheral and coronary angioplasty balloon catheters, polymeric ureteral stents, nephrostomy catheters, and endovascular stents such as the WALLSTENT® Endoprosthesis. Additionally, they offer endoscopy preparation and cleaning kits, as well as devices for embolization and imaging guidance.

Where is Boston Scientific based, and where are its devices manufactured?

Boston Scientific is headquartered in the United States. While the company operates globally, its manufacturing presence is based in the US, which aligns with its regulatory compliance and distribution of devices in markets like the US and Europe.

Which regulatory registries list Boston Scientific’s medical devices?

Boston Scientific’s devices are listed in multiple regulatory registries, including the EU’s eudamed system, the FDA’s 510(k) premarket notification database, and the FDA’s Unique Device Identification (UDI) registry. These listings reflect compliance with regulatory requirements in both the US and European markets.

How are Boston Scientific’s devices classified under medical device regulations?

Boston Scientific’s devices span multiple regulatory classes, including Class I, Class II, Class IIb, Class III, and Unclassified (U). The classification depends on factors like risk level, intended use, and procedural context—for example, stents like the WALLSTENT® Endoprosthesis are typically Class IIb or III due to their higher-risk applications, while single-use catheters may fall under Class II. These classifications determine the regulatory pathway, such as FDA’s 510(k) clearance or EU conformity assessment procedures.

Why do some of Boston Scientific’s devices appear in different regulatory registries?

Devices are listed in multiple registries because they are designed for use in different markets with distinct regulatory frameworks. For instance, the FDA’s 510(k) and UDI systems track devices cleared for the US market, while eudamed records devices compliant with EU regulations. This ensures transparency and compliance across jurisdictions where the devices are marketed or sold.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: United States
Address: 300, Boston Scientific Way, Marlborough, United States
Website: www.bsci.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 001 508-683-4000
PRRC Contact: —
EUDAMED SRN: US-MF-000004702
FDA FEI Number: 3005099803
DUNS Number: —

Catalogue (12354)

Page 15 of 248

Device	Model / Reference	Registries	Class	Status
Woven	M0046FMC005310	FDA UDI	Class II	Active
Wiseguide™	H749195005020	FDA UDI	Class II	Unknown
Expo™	H74908526320A1	FDA UDI	Class II	Active
Symmetry™	M001103560	FDA UDI	Class II	Active
Flexima™	M001281560	FDA UDI	Class II	Active
Rhythmia™ Mapping System	M004RAPWR0	FDA UDI	Class II	Active
Epic™ Vascular	H74939200102070	FDA UDI	Class III	Active
Apex™ Flex	H7493895920150	FDA UDI	Class II	Active
Synergy™	H7493926012250	FDA UDI	Class III	Active
Mach1™	H74934357399A0	FDA UDI	Class II	Active
Contour™	M006180220090	FDA UDI	Class II	Active
Mach1™	H74934358724A0	FDA UDI	Class II	Active
Mach1™	H749343582730	FDA UDI	Class II	Active
Expo™	H74908641251	FDA UDI	Class II	Active
EndoVive One Step Button	M00563140	FDA UDI	Class II	Active
AMS 700 Accessory Kit	72401850	FDA UDI	Class III	Active
Gladiator™ Elite	H74939207061070	FDA UDI	Class II	Active
Polaris™ Ultra	M006192142110	FDA UDI	Class II	Unknown
Mach1™	H749343585150	FDA UDI	Class II	Active
Expo™	H74908526021	FDA UDI	Class II	Active
Polaris™ Ultra	M0061931300	FDA UDI	Class II	Active
Wiseguide™	H749195002680	FDA UDI	Class II	Unknown
RunWay™	H7493896938D0	FDA UDI	Class II	Active
Expo™	H74908526330A1	FDA UDI	Class II	Active
Mach1™	H74934358280	FDA UDI	Class II	Active
Symmetry™ Stiff Shaft	M001105440	FDA UDI	Class II	Active
Polaris™ Ultra	M006192115190	FDA UDI	Class II	Active
AMS 700 LGX™ TENACIO™ Pump	72404400	FDA UDI	Class III	Active
TempLink™	M004210078MA0	FDA UDI	Class III	Unknown
Wiseguide™	H74916320501	FDA UDI	Class II	Unknown
Epic™ Vascular	H74939200087020	FDA UDI	Class III	Active
RunWay™	H7493896925A0	FDA UDI	Class II	Active
RX Cholangiogram Kit	M00575440	FDA UDI	Class II	Active
Maverick™ XL	H7493790940150	FDA UDI	Class II	Active
Symmetry™ Stiff Shaft	M001105410	FDA UDI	Class II	Active
Symmetry™	M001103520	FDA UDI	Class II	Active
Watchman Flx™	M635WU50350	FDA UDI	Class III	Active
Amplatz Super Stiff	M0066401090	FDA UDI	Class I	Active
Embozene®	01-0301-05001-11	FDA UDI	Class II	Active
Expel™ Ureteral Stent System	H7493936108240	FDA UDI	Class II	Active
PROMUS Element™ Plus	H7493911432350	FDA UDI	Class III	Unknown
Emerge™	H7493918915120	FDA UDI	Class II	Active
RX Cholangiogram Kit	M00576160	FDA UDI	Class II	Active
Apex™	H7493895915300	FDA UDI	Class II	Active
Interlock™-35	M001363700	FDA UDI	Class II	Active
Eluvia™	H74939294701510	FDA UDI	Class III	Active
Mach1™	H749343567600	FDA UDI	Class II	Active
Fluoro Tip ERCP Cannula	M00530980	FDA UDI	Class II	Unknown
ICEfx Cryoablation System - Refurbished	FPRCH8000-02R	FDA UDI	Class II	Active
Advanix™ Pancreatic Stent	M00537090	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

Boston Scientific Limited IE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (100)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Boston Scientific has 1192 recall records spanning from April 11, 2000, to March 30, 2026. The records reflect various statuses, including completed, open, classified, and terminated. Recalled items involve issues such as battery performance, mislabeling of device dimensions or components, software updates for safety enhancements, packaging defects compromising sterility, incorrect sheath sizes, potential procedural complications from incorrect implantation, deviations in radial force specifications, battery-related safety mode activations, incorrect labeling and packaging of microcatheters, balloon pressure failures, and manufacturing omissions affecting catheter coatings.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Mar 30, 2026	Z-2048-2026	—	open, classified	For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In addition, for these devices that are not being monitored, the LATITUDE Clarity programming screens have discrepant information, indicating that the monitoring is enabled for these features in one location and not enabled in another location.
Mar 30, 2026	Z-2049-2026	—	open, classified	For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In addition, for these devices that are not being monitored, the LATITUDE Clarity programming screens have discrepant information, indicating that the monitoring is enabled for these features in one location and not enabled in another location.
Mar 19, 2026	Z-1770-2026	—	open, classified	Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 and the advisory population is expanding to include all CRT-P and dual-chamber extended life (DR-EL) devices. Dual chamber modes are specifically indicated for treatment of the following: " Conduction disorders that require restoration of AV synchrony, including varying degrees of AV block " VVI intolerance (i.e., pacemaker syndrome) in the presence of persistent sinus rhythm " Low cardiac output or congestive heart failure secondary to bradycardia
Mar 19, 2026	Z-1771-2026	—	open, classified	Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 and the advisory population is expanding to include all CRT-P and dual-chamber extended life (DR-EL) devices. Dual chamber modes are specifically indicated for treatment of the following: " Conduction disorders that require restoration of AV synchrony, including varying degrees of AV block " VVI intolerance (i.e., pacemaker syndrome) in the presence of persistent sinus rhythm " Low cardiac output or congestive heart failure secondary to bradycardia
Feb 10, 2026	Z-1551-2026	—	open, classified	Recall of kits which utilized ChloraPrep Triple Swabsticks from BD. Open or compromised seals on the sterile swabstick packaging, which could result in loss of sterility or drying of the antiseptic solution. This component is placed outside of the sterile barrier of the tray manufactured by Boston Scientific, which contains the majority of the kit components. As such, inclusion of the affected ChloraPrep Triple Swabsticks does not degrade the integrity of the other components within the PEG kit.
Dec 19, 2025	Z-1163-2026	—	open, classified	Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.
Dec 19, 2025	Z-1159-2026	—	open, classified	Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.
Dec 19, 2025	Z-1161-2026	—	open, classified	Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.
Dec 19, 2025	Z-1162-2026	—	open, classified	Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.
Dec 19, 2025	Z-1158-2026	—	open, classified	Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.
Dec 19, 2025	Z-1160-2026	—	open, classified	Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.
Dec 3, 2025	Z-1042-2026	—	open, classified	Boston Scientific is initiating the removal of certain batches of Coyote" Over-the-Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter devices due to the potential for inflation/deflation difficulty during use in the peripheral vasculature. An internal investigation found that a manufacturing process variation resulted in catheters that may not properly inflate/deflate. This was limited to Coyote OTW batches manufactured from 12Sep2025 through 13Oct2025. The processing variation has since been addressed. No other material numbers or batches are impacted by this removal.
Sep 11, 2025	Z-0143-2026	—	open, classified	The potential for devices to experience inflation and/or deflation performance issues or difficulties.
Sep 11, 2025	Z-0144-2026	—	open, classified	The potential for devices to experience inflation and/or deflation performance issues or difficulties.
Sep 11, 2025	Z-0142-2026	—	open, classified	The potential for devices to experience inflation and/or deflation performance issues or difficulties.
Sep 11, 2025	Z-0140-2026	—	open, classified	The potential for devices to experience inflation and/or deflation performance issues or difficulties.
Sep 11, 2025	Z-0138-2026	—	open, classified	The potential for devices to experience inflation and/or deflation performance issues or difficulties.
Sep 11, 2025	Z-0139-2026	—	open, classified	The potential for devices to experience inflation and/or deflation performance issues or difficulties.
Sep 11, 2025	Z-0141-2026	—	open, classified	The potential for devices to experience inflation and/or deflation performance issues or difficulties.
Aug 28, 2025	Z-2618-2025	—	open, classified	The product in incorrectly labeled. The label indicates that the skive hole should be above the balloon, while it is actually positioned below, and vice versa.
Aug 20, 2025	Z-0095-2026	—	open, classified	Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
Aug 20, 2025	Z-0100-2026	—	open, classified	Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
Aug 20, 2025	Z-0093-2026	—	open, classified	Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
Aug 20, 2025	Z-0088-2026	—	open, classified	Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
Aug 20, 2025	Z-0089-2026	—	open, classified	Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
Aug 20, 2025	Z-0084-2026	—	open, classified	Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
Aug 20, 2025	Z-0090-2026	—	open, classified	Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
Aug 20, 2025	Z-0081-2026	—	open, classified	Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
Aug 20, 2025	Z-0083-2026	—	open, classified	Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
Aug 20, 2025	Z-0098-2026	—	open, classified	Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
Aug 20, 2025	Z-0082-2026	—	open, classified	Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
Aug 20, 2025	Z-0101-2026	—	open, classified	Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
Aug 20, 2025	Z-0094-2026	—	open, classified	Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
Aug 20, 2025	Z-0103-2026	—	open, classified	Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
Aug 20, 2025	Z-0102-2026	—	open, classified	Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
Aug 20, 2025	Z-0096-2026	—	open, classified	Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
Aug 20, 2025	Z-0091-2026	—	open, classified	Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
Aug 20, 2025	Z-0086-2026	—	open, classified	Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
Aug 20, 2025	Z-0097-2026	—	open, classified	Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
Aug 20, 2025	Z-0092-2026	—	open, classified	Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
Aug 20, 2025	Z-0105-2026	—	open, classified	Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
Aug 20, 2025	Z-0079-2026	—	open, classified	Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
Aug 20, 2025	Z-0087-2026	—	open, classified	Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
Aug 20, 2025	Z-0085-2026	—	open, classified	Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
Aug 20, 2025	Z-0080-2026	—	open, classified	Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
Aug 20, 2025	Z-0104-2026	—	open, classified	Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
Aug 20, 2025	Z-0099-2026	—	open, classified	Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
Aug 18, 2025	Z-2551-2025	—	open, classified	Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
Aug 18, 2025	Z-2550-2025	—	open, classified	Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
Aug 5, 2025	Z-2535-2025	—	open, classified	The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could migrate from affected Encore 26 Inflation Devices into a balloon dilatation catheter.
Aug 5, 2025	Z-2536-2025	—	open, classified	The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could migrate from affected Encore 26 Inflation Devices into a balloon dilatation catheter.
Aug 5, 2025	Z-2533-2025	—	open, classified	The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could migrate from affected Encore 26 Inflation Devices into a balloon dilatation catheter.
Aug 5, 2025	Z-2534-2025	—	open, classified	The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could migrate from affected Encore 26 Inflation Devices into a balloon dilatation catheter.
Jul 29, 2025	Z-2431-2025	—	open, classified	Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requiring transseptal access to the left atrium when conscious or deep sedation is used, patients have an approximately three-times higher risk (U.S. study) of negative left atrium pressure and air ingress. This risk is especially prevalent in patients with pre-existing low left atrial pressure, hypovolemia, and partial upper airway collapse.
Jul 29, 2025	Z-2429-2025	—	open, classified	Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requiring transseptal access to the left atrium when conscious or deep sedation is used, patients have an approximately three-times higher risk (U.S. study) of negative left atrium pressure and air ingress. This risk is especially prevalent in patients with pre-existing low left atrial pressure, hypovolemia, and partial upper airway collapse.
Jul 29, 2025	Z-2426-2025	—	open, classified	Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requiring transseptal access to the left atrium when conscious or deep sedation is used, patients have an approximately three-times higher risk (U.S. study) of negative left atrium pressure and air ingress. This risk is especially prevalent in patients with pre-existing low left atrial pressure, hypovolemia, and partial upper airway collapse.
Jul 29, 2025	Z-2434-2025	—	open, classified	Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requiring transseptal access to the left atrium when conscious or deep sedation is used, patients have an approximately three-times higher risk (U.S. study) of negative left atrium pressure and air ingress. This risk is especially prevalent in patients with pre-existing low left atrial pressure, hypovolemia, and partial upper airway collapse.
Jul 29, 2025	Z-2436-2025	—	open, classified	Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requiring transseptal access to the left atrium when conscious or deep sedation is used, patients have an approximately three-times higher risk (U.S. study) of negative left atrium pressure and air ingress. This risk is especially prevalent in patients with pre-existing low left atrial pressure, hypovolemia, and partial upper airway collapse.
Jul 29, 2025	Z-2433-2025	—	open, classified	Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requiring transseptal access to the left atrium when conscious or deep sedation is used, patients have an approximately three-times higher risk (U.S. study) of negative left atrium pressure and air ingress. This risk is especially prevalent in patients with pre-existing low left atrial pressure, hypovolemia, and partial upper airway collapse.
Jul 29, 2025	Z-2430-2025	—	open, classified	Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requiring transseptal access to the left atrium when conscious or deep sedation is used, patients have an approximately three-times higher risk (U.S. study) of negative left atrium pressure and air ingress. This risk is especially prevalent in patients with pre-existing low left atrial pressure, hypovolemia, and partial upper airway collapse.
Jul 29, 2025	Z-2428-2025	—	open, classified	Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requiring transseptal access to the left atrium when conscious or deep sedation is used, patients have an approximately three-times higher risk (U.S. study) of negative left atrium pressure and air ingress. This risk is especially prevalent in patients with pre-existing low left atrial pressure, hypovolemia, and partial upper airway collapse.
Jul 29, 2025	Z-2435-2025	—	open, classified	Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requiring transseptal access to the left atrium when conscious or deep sedation is used, patients have an approximately three-times higher risk (U.S. study) of negative left atrium pressure and air ingress. This risk is especially prevalent in patients with pre-existing low left atrial pressure, hypovolemia, and partial upper airway collapse.
Jul 29, 2025	Z-2427-2025	—	open, classified	Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requiring transseptal access to the left atrium when conscious or deep sedation is used, patients have an approximately three-times higher risk (U.S. study) of negative left atrium pressure and air ingress. This risk is especially prevalent in patients with pre-existing low left atrial pressure, hypovolemia, and partial upper airway collapse.
Jul 29, 2025	Z-2432-2025	—	open, classified	Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requiring transseptal access to the left atrium when conscious or deep sedation is used, patients have an approximately three-times higher risk (U.S. study) of negative left atrium pressure and air ingress. This risk is especially prevalent in patients with pre-existing low left atrial pressure, hypovolemia, and partial upper airway collapse.
Jul 24, 2025	Z-2325-2025	—	open, classified	Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most serious harm is death or need for cardiac resuscitation.
Jul 24, 2025	Z-2327-2025	—	open, classified	Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most serious harm is death or need for cardiac resuscitation.
Jul 24, 2025	Z-2326-2025	—	open, classified	Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most serious harm is death or need for cardiac resuscitation.
Jul 7, 2025	Z-2273-2025	—	open, classified	Certain batches are being removed due to an increase in complaints received in which physicians encountered greater than anticipated resistance while attempting to withdraw the stent delivery system (SDS) from the guidewire or embolic protection device (EPD) after successful stent deployment. The most serious potential adverse health consequence is stroke. Other risks include delay to procedure, vessel injury, vessel spasm, or stent disruption/damage necessitating additional intervention.
Jun 25, 2025	Z-2278-2025	—	open, classified	The potentially impacted units were manufactured using specific equipment that may have caused cracks in the electrode bands on the catheter's distal end.
Jun 10, 2025	Z-2106-2025	—	open, classified	Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potential punctures may go undetected in clinical settings due to small size and variable location.
Jun 10, 2025	Z-2103-2025	—	open, classified	Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potential punctures may go undetected in clinical settings due to small size and variable location.
Jun 10, 2025	Z-2105-2025	—	open, classified	Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potential punctures may go undetected in clinical settings due to small size and variable location.
Jun 10, 2025	Z-2104-2025	—	open, classified	Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potential punctures may go undetected in clinical settings due to small size and variable location.
Mar 24, 2025	Z-1689-2025	—	open, classified	Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings (see Affected Product Listing). Upon initial connection of an IceSeed CX needle to the Cryoablation System, the user will be prompted to perform the Needle Integrity and Functionality Test (NIT) per standard protocols. The affected needles perform as intended unless they are disconnected and reconnected to any channel after testing. In this case, the Cryoablation System will prompt re-execution of the NIT.
Mar 24, 2025	Z-1686-2025	—	open, classified	Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings (see Affected Product Listing). Upon initial connection of an IceSeed CX needle to the Cryoablation System, the user will be prompted to perform the Needle Integrity and Functionality Test (NIT) per standard protocols. The affected needles perform as intended unless they are disconnected and reconnected to any channel after testing. In this case, the Cryoablation System will prompt re-execution of the NIT.
Mar 24, 2025	Z-1687-2025	—	open, classified	Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings (see Affected Product Listing). Upon initial connection of an IceSeed CX needle to the Cryoablation System, the user will be prompted to perform the Needle Integrity and Functionality Test (NIT) per standard protocols. The affected needles perform as intended unless they are disconnected and reconnected to any channel after testing. In this case, the Cryoablation System will prompt re-execution of the NIT.
Mar 24, 2025	Z-1688-2025	—	open, classified	Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings (see Affected Product Listing). Upon initial connection of an IceSeed CX needle to the Cryoablation System, the user will be prompted to perform the Needle Integrity and Functionality Test (NIT) per standard protocols. The affected needles perform as intended unless they are disconnected and reconnected to any channel after testing. In this case, the Cryoablation System will prompt re-execution of the NIT.
Dec 20, 2024	Z-1027-2025	—	open, classified	Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Dec 20, 2024	Z-1024-2025	—	open, classified	Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Dec 20, 2024	Z-1034-2025	—	open, classified	Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Dec 20, 2024	Z-1035-2025	—	open, classified	Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Dec 20, 2024	Z-1030-2025	—	open, classified	Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Dec 20, 2024	Z-1029-2025	—	open, classified	Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Dec 20, 2024	Z-1032-2025	—	open, classified	Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Dec 20, 2024	Z-1036-2025	—	open, classified	Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Dec 20, 2024	Z-1037-2025	—	open, classified	Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Dec 20, 2024	Z-1026-2025	—	open, classified	Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Dec 20, 2024	Z-1025-2025	—	open, classified	Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Dec 20, 2024	Z-1031-2025	—	open, classified	Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Dec 20, 2024	Z-1028-2025	—	open, classified	Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Dec 20, 2024	Z-1033-2025	—	open, classified	Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Dec 12, 2024	Z-0825-2025	—	open, classified	A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.
Dec 12, 2024	Z-0822-2025	—	open, classified	A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.
Dec 12, 2024	Z-0826-2025	—	open, classified	A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.
Dec 12, 2024	Z-0823-2025	—	open, classified	A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.
Dec 12, 2024	Z-0824-2025	—	open, classified	A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.
Dec 12, 2024	Z-0827-2025	—	open, classified	A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.
Oct 28, 2024	Z-0531-2025	—	open, classified	Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN 72400098)
Oct 28, 2024	Z-0530-2025	—	open, classified	Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN 72400098)
Oct 10, 2024	Z-0303-2025	—	open, classified	Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.

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Boston Scientific Corporation Mississauga Ontario · CA FEI 3019751610