The Recall Desk

Manufacturer

Boston Scientific Corporation

639 recalls in our database name Boston Scientific Corporation as the manufacturing or recalling firm.

What the numbers show

Total
639
Critical
57
Severe
102
Most recent
2026-09-09

Of the 639 recalls from Boston Scientific Corporation we have scored against our rubric, 57 (9%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 102 (16%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

51–75 of 639

  • CriticalFDA (Devices)·Z-0104-2026·2025-10-22

    VISIONIST extended life pacemakers recalled for Safety Mode software update

    Boston Scientific is recalling 1,050 VISIONIST CRT-P EL devices under model U226, part of a software update designed to prevent Safety Mode starting outside hospital.

    Product
    Model Number U226, VISIONIST CRT-P EL
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0083-2026·2025-10-22

    ACCOLADE dual chamber extended life pacemakers recalled for software update

    Boston Scientific is recalling 7,488 ACCOLADE DR EL pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.

    Product
    ACCOLADE DR EL (Model L321)
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0087-2026·2025-10-22

    PROPONENT VDD pacemakers recalled for Safety Mode software architecture update

    Boston Scientific is recalling 3,146 PROPONENT DR (VDD) SL pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.

    Product
    Model Number L209 PROPONENT DR (VDD) SL Pacemaker
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0094-2026·2025-10-22

    ESSENTIO single chamber MRI pacemakers recalled for Safety Mode software update

    Boston Scientific is recalling 61,700 ESSENTIO SR SL MRI pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.

    Product
    Model Number L110, ESSENTIO SR SL MRI Pacemaker
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0102-2026·2025-10-22

    VALITUDE MRI resynchronization pacemakers recalled for Safety Mode software update

    Boston Scientific is recalling 28,911 VALITUDE CRT-P EL MRI devices, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.

    Product
    Model Number U128, VALITUDE CRT-P EL MRI
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0080-2026·2025-10-22

    ACCOLADE dual chamber standard life pacemakers recalled for software update

    Boston Scientific is recalling 32,695 ACCOLADE DR SL pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.

    Product
    ACCOLADE DR SL (Model L301)
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0084-2026·2025-10-22

    ACCOLADE dual chamber extended life MRI pacemakers recalled for software update

    Boston Scientific is recalling 34,180 ACCOLADE DR EL MRI pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.

    Product
    ACCOLADE DR EL MRI (Model L331)
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0079-2026·2025-10-22

    ACCOLADE single chamber standard life pacemakers recalled for software update

    Boston Scientific is recalling 16,077 ACCOLADE SR SL pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.

    Product
    ACCOLADE SR SL (Model L300)
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0101-2026·2025-10-22

    VALITUDE resynchronization pacemakers recalled for Safety Mode software update

    Boston Scientific is recalling 3,620 VALITUDE CRT-P EL devices, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.

    Product
    Model Number U125, VALITUDE CRT-P EL
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0095-2026·2025-10-22

    Pacemakers recalled for software update preventing Safety Mode from battery impedance

    Boston Scientific is recalling 223,163 ESSENTIO DR SL MRI pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.

    Product
    Model Number L111, ESSENTIO DR SL MRI Pacemaker
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0098-2026·2025-10-22

    ALTRUA 2 single chamber pacemakers recalled for Safety Mode software update

    Boston Scientific is recalling 4,841 ALTRUA 2 SR SL pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.

    Product
    Model Number S701 ALTRUA 2 SR SL Pacemaker
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0093-2026·2025-10-22

    ESSENTIO dual chamber pacemakers recalled for Safety Mode software update

    Boston Scientific is recalling 22,714 ESSENTIO DR SL pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.

    Product
    Model Number L101, ESSENTIO DR SL Pacemaker
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0105-2026·2025-10-22

    VISIONIST MRI resynchronization pacemakers recalled for Safety Mode software update

    Boston Scientific is recalling 41,191 VISIONIST CRT-P EL MRI devices, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.

    Product
    Model Number U228, VISIONIST CRT-P EL MRI
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0090-2026·2025-10-22

    PROPONENT pacemakers recalled for Safety Mode software architecture update

    Boston Scientific is recalling 3,592 PROPONENT DR EL pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.

    Product
    Model Number L221 PROPONENT DR EL Pacemaker
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0088-2026·2025-10-22

    PROPONENT single chamber pacemakers recalled for Safety Mode software update

    Boston Scientific is recalling 41,009 PROPONENT SR SL pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.

    Product
    Model Number L210 PROPONENT SR SL Pacemaker
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0091-2026·2025-10-22

    PROPONENT dual chamber extended life MRI pacemakers recalled for software update

    Boston Scientific is recalling 63,851 PROPONENT DR EL MRI pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.

    Product
    Model Number L231, PROPONENT DR EL MRI Pacemaker
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0100-2026·2025-10-22

    ALTRUA 2 dual chamber extended life pacemakers recalled for software update

    Boston Scientific is recalling 3,376 ALTRUA 2 DR EL pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.

    Product
    Model Number S722, ALTRUA 2 DR EL Pacemaker
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0089-2026·2025-10-22

    PROPONENT dual chamber pacemakers recalled for Safety Mode software update

    Boston Scientific is recalling 106,536 PROPONENT DR SL MRI pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.

    Product
    Model Number L211 PROPONENT DR SL MRI Pacemaker
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0081-2026·2025-10-22

    ACCOLADE single chamber pacemakers recalled for Safety Mode software update

    Boston Scientific is recalling 50,135 ACCOLADE SR SL MRI pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.

    Product
    ACCOLADE SR SL MRI (Model L310)
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0099-2026·2025-10-22

    ALTRUA 2 dual chamber pacemakers recalled for Safety Mode software update

    Boston Scientific is recalling 4,055 ALTRUA 2 DR SL pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.

    Product
    Model Number S702, ALTRUA 2 DR SL Pacemaker
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0085-2026·2025-10-22

    PROPONENT single chamber standard life pacemakers recalled for software update

    Boston Scientific is recalling 1,380 PROPONENT SR SL pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.

    Product
    PROPONENT SR SL (Model L200)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0144-2026·2025-10-22

    LGX preconnect pumps recalled over inflation and deflation performance issues

    Boston Scientific is recalling 490 LGX Preconnect devices with TENACIO Pump and InhibiZone because of the potential for inflation or deflation performance issues or difficulties.

    Product
    LGX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404450 (12CM PS IZ), (2) 72404451 (15CM PS IZ), (3) 72404452 (18CM PS IZ), (4) 72404453 (21CM PS IZ), (5) 72404455 (12CM IP IZ), (6) 72404456 (15CM IP IZ), (7) 72404457 (18CM IP IZ), (8) 72404458 (21CM IP IZ);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0141-2026·2025-10-22

    LGX preconnect pumps without InhibiZone recalled over inflation deflation issues

    Boston Scientific is recalling LGX Preconnect with TENACIO Pump without InhibiZone because of the potential for inflation or deflation performance issues or difficulties.

    Product
    LGX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404405 (12CM IP), (2) 72404407 (18CM IP);
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Boston Scientific

worldwide developer, manufacturer and marketer of medical devices

Country
United States
Founded
1979

Official website

Source: Wikidata (Q894585), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.