Boston Scientific
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000004702 FEI 3005099803
- Devices
- 13,580
- Registrations
- EUDAMEDFDA
- FDA recalls
- 1,257375 ongoing since 2021 (434 open in total)
At a glance
EU certificates
15 of 19 in force.
Market reach
- European Union
- EUDAMED actor, 19 certificates
- United States
- FDA establishment, FDA recalls
- Authorised rep.
- Boston Scientific LimitedIE
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.
Catalogue
Search and filter all 13,580 devicesShowing 1-50 of 13,580
Company details
- EUDAMED SRN
- US-MF-000004702
- SRN (system / procedure pack)
- US-PR-000008885
- FDA FEI number
- 3005099803
- EUDAMED status
- Active
- EUDAMED registered name
- Boston Scientific Corporation
- Registered address
- 300, Boston Scientific Way, MA 01752, Marlborough, United States
- Website
- www.bsci.com
- eudamed@bsci.com
- Phone
- 001 508-683-4000
- PRRC contact
- Alexandra (Ali) Naughton
EUDAMED certificates
19 certificates15 valid, 0 expired, 4 withdrawn or suspendedMDR 19next expiry 15 Nov 2026
DEKRA Certification B.V. 0344 10 certificates
- 3827895TD12 Active
Technical documentation EU MDR
- Issued
- 28 May 2025
- Expires
- 28 May 2030
- 3827895TD10 Active
Technical documentation EU MDR
- Issued
- 15 Sep 2026
- Expires
- 20 Aug 2029
- Reason
- Other
- 3827895TD06 Active
Technical documentation EU MDR
- Issued
- 6 Feb 2024
- Expires
- 16 Jan 2029
- Reason
- Mnf data change
- 3827895TD05 Active
Technical documentation EU MDR
- Issued
- 15 Oct 2024
- Expires
- 7 Dec 2028
- Reason
- Change approved
- 3827895TD03 Active
Technical documentation EU MDR
- Issued
- 7 Jul 2023
- Expires
- 7 Jul 2028
- 3827895TD02 Active
Technical documentation EU MDR
- Issued
- 22 Mar 2023
- Expires
- 22 Mar 2028
- 3827895CE01 Expiring
Quality management system EU MDR
- Issued
- 15 Sep 2026
- Expires
- 28 Oct 2027
- Reason
- Other
- 3830129CE01 Expiring
Quality management system EU MDR
- Issued
- 15 Dec 2025
- Expires
- 25 Oct 2027
- Reason
- Add device or group
- 3829852CE01 Restricted
Quality management system EU MDR
- Issued
- 22 Jul 2026
- Expires
- 1 Jun 2027
- Reason
- Not on market
- 3827961CE01 Expiring
Quality management system EU MDR
- Issued
- 4 Aug 2026
- Expires
- 15 Nov 2026
- Reason
- Add device or group
TÜV SÜD Product Service GmbH 0123 4 certificates
- G10 097167 0039 Cancelled
Quality management system EU MDR
- Issued
- 6 Apr 2023
- Expires
- 5 Apr 2028
- Reason
- Other
- G11 097167 0049 Cancelled
Quality management system EU MDR
- Issued
- 6 Apr 2023
- Expires
- 5 Apr 2028
- Reason
- Other
- G12 097167 0051 Cancelled
Quality management system EU MDR
- Issued
- 6 Apr 2023
- Expires
- 5 Apr 2028
- Reason
- Other
- G70 097167 0040 Cancelled
Technical documentation EU MDR
- Issued
- 23 Mar 2023
- Expires
- 22 Mar 2028
- Reason
- Other
BSI Group The Netherlands B.V. 2797 3 certificates
- MDR 813080 Active
Technical documentation EU MDR
- Issued
- 11 Sep 2026
- Expires
- 17 Jun 2030
- Reason
- Change approved
- MDR 785454 Active
Technical documentation EU MDR
- Issued
- 10 Jul 2026
- Expires
- 13 Nov 2029
- Reason
- Other
- MDR 735044 Expiring
Technical documentation EU MDR
- Issued
- 11 Sep 2026
- Expires
- 21 Apr 2027
- Reason
- Change approved
GMED SAS 0459 2 certificates
- 39506 Expiring
Quality management system EU MDR
- Issued
- 28 Jul 2026
- Expires
- 2 Aug 2027
- Reason
- Other
- 40355 Expiring
Quality management system EU MDR
- Issued
- 20 Jul 2026
- Expires
- 2 Aug 2027
- Reason
- Other
FDA recalls
FDA recall records list 1256 recalls initiated by Boston Scientific, the earliest on 2000-04-11 and the most recent on 2026-09-10. By recorded status: 434 ongoing, 783 terminated and 39 with another status. The reasons filed fall into these groups: labeling or instructions for use, software or firmware, sterility or contamination, packaging, electrical or power, mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 51
- 2018 25
- 2019 34
- 2020 97
- 2021 66
- 2022 21
- 2023 33
- 2024 148
- 2025 72
- 2026 42
2026
- 10 Sep 2026 Z-0143-2027 Class II Ongoing Device was incorrectly manufactured with a guidewire exit port (referred to in the IFU as the RX port), which is not a design feature associated with this device configuration.
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- 24 Aug 2026 Z-3214-2026 Class I Ongoing Tip may fracture or detach, leading to device fragments remaining within the patient or migrating through the vasculature. Patient impact may include prolonged procedure or life-threatening embolism.
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- 6 Aug 2026 Z-3081-2026 Class II Ongoing There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed notification of an AF Burden Alert may delay clinical evaluation or therapeutic intervention of an atrial arrhythmia.
- 6 Aug 2026 Z-3082-2026 Class II Ongoing There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed notification of an AF Burden Alert may delay clinical evaluation or therapeutic intervention of an atrial arrhythmia.
- 6 Aug 2026 Z-3083-2026 Class II Ongoing There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed notification of an AF Burden Alert may delay clinical evaluation or therapeutic intervention of an atrial arrhythmia.
- 22 Jul 2026 Z-3188-2026 Class II Ongoing A subset of power adapters used with the connect console may exhibit higher-than-expected resistance in the electrical grounding path. As a result, the power adaptor may fail electrical safety testing during installation.
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- 14 Jul 2026 Z-2961-2026 Class II Ongoing Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.
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- 14 Jul 2026 Z-2962-2026 Class II Ongoing Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.
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- 9 Jul 2026 Z-2977-2026 Class I Ongoing Potential for arterial sheath tip separation or partial tip separation during use.
- 9 Jul 2026 Z-2978-2026 Class I Ongoing Potential for arterial sheath tip separation or partial tip separation during use.
- 10 Sep 2026 Z-0143-2027 Class II Ongoing Device was incorrectly manufactured with a guidewire exit port (referred to in the IFU as the RX port), which is not a design feature associated with this device configuration.
Show the 25 most recent of 1,257 recalls
2026
- 30 Jun 2026 Z-2725-2026 Class II Ongoing Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe loosening or disconnecting from the manifold, resulting in loose connection or complete disconnection. May lead to difficulty connecting syringe, inability to aspirate or inject properly, fluid leakage, or separation of the syringe from the system, potentially requiring device exchange and prolonging the procedure.
- 30 Jun 2026 Z-2838-2026 Class II Ongoing Potential for breach in sterile barrier of device packaging.
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- 30 Jun 2026 Z-2839-2026 Class II Ongoing Potential for breach in sterile barrier of device packaging.
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- 30 Jun 2026 Z-2840-2026 Class II Ongoing Potential for breach in sterile barrier of device packaging.
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- 19 Jun 2026 Z-2771-2026 Class II Ongoing Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activity Calculator to modify one or more input. When a user modifies an input and selects "Recalculate", the dose calculation is updated correctly; however, any vials that were previously added to the cart are not automatically updated to reflect the revised calculation.
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- 11 Jun 2026 Z-2750-2026 Class II Ongoing Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include
FARAPOINT PFA catheter information.
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- 11 Jun 2026 Z-2751-2026 Class II Ongoing Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include
FARAPOINT PFA catheter information.
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- 11 Jun 2026 Z-2752-2026 Class II Ongoing Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include
FARAPOINT PFA catheter information.
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- 11 Jun 2026 Z-2753-2026 Class II Ongoing Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.
- 11 Jun 2026 Z-2754-2026 Class II Ongoing Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator straight through the center of the valve and fully advancing it into the sheath body.
- 11 Jun 2026 Z-2755-2026 Class II Ongoing Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator straight through the center of the valve and fully advancing it into the sheath body.
- 11 Jun 2026 Z-2756-2026 Class II Ongoing Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator straight through the center of the valve and fully advancing it into the sheath body.
- 11 Jun 2026 Z-2757-2026 Class II Ongoing Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator straight through the center of the valve and fully advancing it into the sheath body.
- 21 May 2026 Z-2626-2026 Class II Ongoing Potential sterile breach of the pouches in which devices are packaged.
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- 21 May 2026 Z-2627-2026 Class II Ongoing Potential sterile breach of the pouches in which devices are packaged.
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FDA establishments
- Boston Scientific Corporation Mississauga Ontario · CA FEI 3019751610
Frequently asked questions
How many devices does Boston Scientific have in the registry?
The registry currently lists 13580 devices for Boston Scientific. Devices recorded under merged duplicate company entries are counted once.
Which registries list Boston Scientific's devices?
Among its 50 most recently registered devices, Boston Scientific has devices listed in EUDAMED (49 devices) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Boston Scientific's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Boston Scientific's devices are Class IIa, Class IIb, Class II and Class III. Each device page shows its own class and authorisation.
Are there FDA recall records for Boston Scientific?
FDA recall records list 1257 recalls initiated by Boston Scientific, the most recent initiated on 10 Sep 2026. 434 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What EUDAMED certificates are recorded for Boston Scientific?
EUDAMED lists 19 certificates for Boston Scientific (technical documentation; quality management system) under MDR. 3 are recorded with the status issued. The most recent was issued on 15 Sep 2026.
What are the newest devices from Boston Scientific in the registry?
The most recently registered devices listed for Boston Scientific include OPAL HDx™ M004OPAL14010, ACUITY™, WALLSTENT-Uni™ and Multi-Point Thermal Sensor.