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Boston Scientific Recalls
651 recalls on record · June 27, 2012 to August 12, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
January 24, 2018Medical DevicesFDA
Boston Scientific Corporation recalls PROPONENT MRI Pacemaker
Hazard: Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
January 24, 2018Medical DevicesFDA
Boston Scientific Corporation recalls PROPONENT VDD SL Pacemaker
Hazard: Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
January 24, 2018Medical DevicesFDA
Boston Scientific Corporation recalls PROPONENT EL DR Pacemaker
Hazard: Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
January 24, 2018Medical DevicesFDA
Boston Scientific Corporation recalls PROPONENT DR Pacemaker
Hazard: Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
January 24, 2018Medical DevicesFDA
Boston Scientific Corporation recalls PROPONENT SR Pacemaker
Hazard: Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
January 24, 2018Medical DevicesFDA
Boston Scientific Corporation recalls ESSENTIO MRI EL DR Pacemaker
Hazard: Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
January 24, 2018Medical DevicesFDA
Boston Scientific Corporation recalls ESSENTIO EL DR Pacemaker
Hazard: Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
January 24, 2018Medical DevicesFDA
Boston Scientific Corporation recalls ESSENTIO MRI DR Pacemaker
Hazard: Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
January 24, 2018Medical DevicesFDA
Boston Scientific Corporation recalls ESSENTIO MRI SR Pacemaker
Hazard: Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
January 24, 2018Medical DevicesFDA
Boston Scientific Corporation recalls ESSENTIO DR Pacemaker
Hazard: Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
January 24, 2018Medical DevicesFDA
Boston Scientific Corporation recalls ESSENTIO SR Pacemaker
Hazard: Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
January 24, 2018Medical DevicesFDA
Boston Scientific Corporation recalls VISIONIST X4 CRT-P Pacemaker
Hazard: Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
January 24, 2018Medical DevicesFDA
Boston Scientific Corporation recalls VISIONIST CRT-P Pacemaker
Hazard: Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
January 24, 2018Medical DevicesFDA
Boston Scientific Corporation recalls ALTRUA 2 EL DR Pacemaker
Hazard: Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
January 24, 2018Medical DevicesFDA
Boston Scientific Corporation recalls ALTRUA 2 DR Pacemaker
Hazard: Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
January 24, 2018Medical DevicesFDA
Boston Scientific Corporation recalls ALTRUA 2 SR Pacemaker
Hazard: Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
January 24, 2018Medical DevicesFDA
Boston Scientific Corporation recalls VALITUDE X4 CRT-P Pacemaker
Hazard: Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
January 24, 2018Medical DevicesFDA
Boston Scientific Corporation recalls VALITUDE CRT-P Pacemaker
Hazard: Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
January 24, 2018Medical DevicesFDA
Boston Scientific Corporation recalls ACCOLADE MRI EL DR Pacemaker
Hazard: Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
January 24, 2018Medical DevicesFDA
Boston Scientific Corporation recalls ACCOLADE MRI DR Pacemaker
Hazard: Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
January 24, 2018Medical DevicesFDA
Boston Scientific Corporation recalls ACCOLADE MRI SR Pacemaker
Hazard: Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
January 24, 2018Medical DevicesFDA
Boston Scientific Corporation recalls ACCOLADE EL DR Pacemaker
Hazard: Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
January 24, 2018Medical DevicesFDA
Boston Scientific Corporation recalls ACCOLADE DR Pacemaker
Hazard: Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
January 24, 2018Medical DevicesFDA
Boston Scientific Corporation recalls ACCOLADE SR Pacemaker
Hazard: Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
November 15, 2017Medical DevicesFDA
Boston Scientific Corporation recalls RESONATE X4 CRT-D, Model G447, Sterile.
Hazard: The devices have an incorrect firmware configuration.
November 15, 2017Medical DevicesFDA
Boston Scientific Corporation recalls MOMENTUM X4 CRT-D, Model G138, Sterile.
Hazard: The devices have an incorrect firmware configuration.
November 15, 2017Medical DevicesFDA
Boston Scientific Corporation recalls VIGILANT X4 CRT-D, Model G247, Sterile. Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for
Hazard: The devices have an incorrect firmware configuration.
November 15, 2017Medical DevicesFDA
Boston Scientific Corporation recalls RESONATE EL ICD DR, Model D433, Sterile.
Hazard: The devices have an incorrect firmware configuration.
November 15, 2017Medical DevicesFDA
Boston Scientific Corporation recalls RESONATE EL ICD VR, Model D432, Sterile.
Hazard: The devices have an incorrect firmware configuration.
September 20, 2017Medical DevicesFDA
Boston Scientific Corporation recalls FFR Link-FFR Signal Processing Module, Material Number H7495551000 It is intended to condition physiological signals fr
Hazard: The device history record (DHR) was missing its test documentation for final HIPOT (high potential) electrical testing.