RecallWatchMedical Device Safety

Recall database

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) recalls

Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.

Showing 1–8 of 8 recalls

Class IOngoingZ-1771-2026

Boston Scientific Corporation recalls Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT…

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 t…

Boston Scientific Corp…MNMay 6, 2026

Class IOngoingZ-0105-2026

Boston Scientific Corporation recalls Model Number U228

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 AC…

Boston Scientific Corp…MNOct 22, 2025

Class IOngoingZ-0104-2026

Boston Scientific Corporation recalls Model Number U226

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 AC…

Boston Scientific Corp…MNOct 22, 2025

Class IOngoingZ-0103-2026

Boston Scientific Corporation recalls Model Number U225 VISIONIST CRT-P EL

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 AC…

Boston Scientific Corp…MNOct 22, 2025

Class IOngoingZ-0102-2026

Boston Scientific Corporation recalls Model Number U128

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 AC…

Boston Scientific Corp…MNOct 22, 2025

Class IOngoingZ-0101-2026

Boston Scientific Corporation recalls Model Number U125

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 AC…

Boston Scientific Corp…MNOct 22, 2025

Class IOngoingZ-0827-2025

Boston Scientific Corporation recalls VISIONIST CRT-P

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 lat…

Boston Scientific Corp…MNJan 22, 2025

Class IOngoingZ-0826-2025

Boston Scientific Corporation recalls VALITUDE CRT-P

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 lat…

Boston Scientific Corp…MNJan 22, 2025