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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 22 of 248

Device	Model / Reference	Registries	Class	Status
Sterling™	H74939031406010	FDA UDI	Class II	Active
ACUITY™ X4 Spiral L	4678	FDA UDI	Class III	Active
Emerge™	H7493918930320	FDA UDI	Class II	Active
IntellaNav™ XP	M004R4500THN40	FDA UDI	Class III	Active
Coyote™	H74939186401510	FDA UDI	Class II	Active
Viking™ Soft Tip	M0044005350	FDA UDI	Class II	Active
EMBOLD™ Fibered	M001394240050150	FDA UDI	Class II	Active
Polaris™ Loop	M006155214050	FDA UDI	Class II	Unknown
Mach1™	H749343566620	FDA UDI	Class II	Active
Resolution Clip	M00522600	FDA UDI	Class II	Active
Expo™	H74908738861	FDA UDI	Class II	Active
Symmetry™	M001103240	FDA UDI	Class II	Active
Percuflex™ Biliary	M00533640	FDA UDI	Class II	Active
Wiseguide™	H74916320381	FDA UDI	Class II	Unknown
Graspit	M0063204020	FDA UDI	Class II	Unknown
RunWay™	H74938969575B0	FDA UDI	Class II	Active
AngioJet® Spiroflex® VG	106608-001	FDA UDI	Class III	Active
Advanix™ Biliary	M00534230	FDA UDI	Class II	Active
Tria™ Firm	M0061902810	FDA UDI	Class II	Active
Ion™	H7493902424250	FDA UDI	Class III	Unknown
Polaris™ Ultra	M006192123060	FDA UDI	Class II	Unknown
Chilli II®	M00490310	FDA UDI	Class III	Unknown
Mach1™	H74934358080	FDA UDI	Class II	Active
NC Emerge®	H7493926830270	FDA UDI	Class II	Active
Bagley	M0063401210	FDA UDI	Class II	Unknown
RX Cholangiogram Kit	M00575230	FDA UDI	Class II	Active
Ranger™	H74939733410020	FDA UDI	Class III	Active
Athletis™	H74939347060250	FDA UDI	Class II	Active
Wolverine Coronary Cutting Balloon	H74939401064000	FDA UDI	Class III	Active
Sterling™	H74939031651610	FDA UDI	Class II	Active
Percuflex™ Plus	M0061755710	FDA UDI	Class II	Active
Impulse™	H74916391241	FDA UDI	Class II	Active
RunWay™	H749389691910	FDA UDI	Class II	Active
Eluvia™	H74939294601070	FDA UDI	Class III	Active
Coyote™	H74939185400610	FDA UDI	Class II	Active
Woven	M0040085670	FDA UDI	Class II	Active
Flexima™	M001271890	FDA UDI	Class I	Active
AMS 700 LGX MS Pump	72404250	FDA UDI	Class III	Active
WallFlex™ Biliary	M00547420	FDA UDI	Class II	Active
Mach1™	H749343583940	FDA UDI	Class II	Active
Symmetry™ Stiff Shaft	M001105690	FDA UDI	Class II	Active
Ascerta™	M0061456150	FDA UDI	Class II	Active
Imager™ Ii	M001314130	FDA UDI	Class II	Active
RX Biliary	M00545580	FDA UDI	Class II	Active
Interlock™-35	M001363620	FDA UDI	Class II	Active
NC Emerge®	H7493926720250	FDA UDI	Class II	Active
Polaris™ Ultra	M006193125090	FDA UDI	Class II	Active
Maverick²™	H7493892809400	FDA UDI	Class II	Active
Direxion™ HI-FLO™	M001195430	FDA UDI	Class II	Active
Mustang™	H74939171032070	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