Boston Scientific Corporation Recalls

All product recalls associated with Boston Scientific Corporation.

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Recall Summary

Total Recalls

238

Past Year

59

Class I (Serious)

0

Most Recent

Sep 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–20 of 238 recalls

LGX Preconnect TENACIO Pump (Boston Scientific) – Inflation Problem (2025)

The potential for devices to experience inflation and/or deflation performance issues or difficulties.

Moderate

FDASep 11, 2025Nationwide• Boston Scientific Corporation

CX Preconnect TENACIO Pump (Boston Scientific) – Inflation Issue (2025)

The potential for devices to experience inflation and/or deflation performance issues or difficulties.

Moderate

FDASep 11, 2025Nationwide• Boston Scientific Corporation

TENACIO Pump without InhibiZone (Boston Scientific) – Inflation Issue (2025)

The potential for devices to experience inflation and/or deflation performance issues or difficulties.

Moderate

FDA

Sep 11, 2025

Nationwide

• Boston Scientific Corporation

CXR Preconnect TENACIO Pump (Boston Scientific) – Inflation Issue (2025)

The potential for devices to experience inflation and/or deflation performance issues or difficulties.

Moderate

FDASep 11, 2025Nationwide• Boston Scientific Corporation

TENACIO Pump with InhibiZone (Boston Scientific) – Inflation Problem (2025)

The potential for devices to experience inflation and/or deflation performance issues or difficulties.

Moderate

FDASep 11, 2025Nationwide• Boston Scientific Corporation

Extractor Pro Retrieval Catheter (Boston Scientific) – Incorrect Labeling (2025)

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.

Moderate

FDAAug 28, 2025Nationwide• Boston Scientific Corporation

ESSENTIO DR SL MRI Pacemaker (Boston Scientific) – Safety Mode Issue (2025)

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).

Moderate

FDAAug 20, 2025Nationwide• Boston Scientific Corporation

ESSENTIO DR EL Pacemaker (Boston Scientific) – Safety Mode Issue (2025)

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).

Moderate

FDAAug 20, 2025Nationwide• Boston Scientific Corporation

ALTRUA 2 DR EL Pacemaker (Boston Scientific) – Safety Mode Issue (2025)

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).

Moderate

FDAAug 20, 2025Nationwide• Boston Scientific Corporation

ACCOLADE DR SL Pacemaker (Boston Scientific) – Safety Mode Issue (2025)

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).

Moderate

FDAAug 20, 2025Nationwide• Boston Scientific Corporation

ESSENTIO DR EL MRI Pacemaker (Boston Scientific) – Safety Mode Issue (2025)

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).

Moderate

FDAAug 20, 2025Nationwide• Boston Scientific Corporation

PROPONENT DR EL Pacemaker (Boston Scientific) – Safety Mode Issue (2025)

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).

Moderate

FDAAug 20, 2025Nationwide• Boston Scientific Corporation

VISIONIST CRT-P EL Pacemaker (Boston Scientific) – Safety Mode Issue (2025)

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).

Moderate

FDAAug 20, 2025Nationwide• Boston Scientific Corporation

ACCOLADE SR SL Pacemaker (Boston Scientific) – Safety Mode Issue (2025)

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).

Moderate

FDAAug 20, 2025Nationwide• Boston Scientific Corporation

PROPONENT SR SL Pacemaker (Boston Scientific) – Safety Mode Issue (2025)

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).

Moderate

FDAAug 20, 2025Nationwide• Boston Scientific Corporation

VISIONIST CRT-P EL Pacemaker (Boston Scientific) – Safety Mode Issue (2025)

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).

Moderate

FDAAug 20, 2025Nationwide• Boston Scientific Corporation

PROPONENT DR VDD SL Pacemaker (Boston Scientific) – Safety Mode Issue (2025)

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).

Moderate

FDAAug 20, 2025Nationwide• Boston Scientific Corporation

VALITUDE CRT-P EL Pacemaker (Boston Scientific) – Safety Mode Issue (2025)

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).

Moderate

FDAAug 20, 2025Nationwide• Boston Scientific Corporation

ESSENTIO SR SL Pacemaker (Boston Scientific) – Safety Mode Issue (2025)

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).

Moderate

FDAAug 20, 2025Nationwide• Boston Scientific Corporation

ACCOLADE DR EL MRI Pacemaker (Boston Scientific) – Safety Mode Issue (2025)

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).

Moderate

FDAAug 20, 2025Nationwide• Boston Scientific Corporation

Stay Informed

Boston Scientific Corporation Recalls

Recall Summary

LGX Preconnect TENACIO Pump (Boston Scientific) – Inflation Problem (2025)

CX Preconnect TENACIO Pump (Boston Scientific) – Inflation Issue (2025)

TENACIO Pump without InhibiZone (Boston Scientific) – Inflation Issue (2025)

CXR Preconnect TENACIO Pump (Boston Scientific) – Inflation Issue (2025)

TENACIO Pump with InhibiZone (Boston Scientific) – Inflation Problem (2025)

Extractor Pro Retrieval Catheter (Boston Scientific) – Incorrect Labeling (2025)

ESSENTIO DR SL MRI Pacemaker (Boston Scientific) – Safety Mode Issue (2025)

ESSENTIO DR EL Pacemaker (Boston Scientific) – Safety Mode Issue (2025)

ALTRUA 2 DR EL Pacemaker (Boston Scientific) – Safety Mode Issue (2025)

ACCOLADE DR SL Pacemaker (Boston Scientific) – Safety Mode Issue (2025)

ESSENTIO DR EL MRI Pacemaker (Boston Scientific) – Safety Mode Issue (2025)

PROPONENT DR EL Pacemaker (Boston Scientific) – Safety Mode Issue (2025)

VISIONIST CRT-P EL Pacemaker (Boston Scientific) – Safety Mode Issue (2025)

ACCOLADE SR SL Pacemaker (Boston Scientific) – Safety Mode Issue (2025)

PROPONENT SR SL Pacemaker (Boston Scientific) – Safety Mode Issue (2025)

VISIONIST CRT-P EL Pacemaker (Boston Scientific) – Safety Mode Issue (2025)

PROPONENT DR VDD SL Pacemaker (Boston Scientific) – Safety Mode Issue (2025)

VALITUDE CRT-P EL Pacemaker (Boston Scientific) – Safety Mode Issue (2025)

ESSENTIO SR SL Pacemaker (Boston Scientific) – Safety Mode Issue (2025)

ACCOLADE DR EL MRI Pacemaker (Boston Scientific) – Safety Mode Issue (2025)