With Cardiac Resynchronization (Crt-P) Implantable Pacemaker Pulse Generator recalls
The FDA has posted 8 enforcement recalls of with cardiac resynchronization (crt-p) implantable pacemaker pulse generator devices since 2025, including 8 Class I (most serious) recalls. Most recent report: May 6, 2026.
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…
With Cardiac Resynchronization (Crt-P) Implantable Pacemaker Pulse Generator
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…
With Cardiac Resynchronization (Crt-P) Implantable Pacemaker Pulse Generator
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…
With Cardiac Resynchronization (Crt-P) Implantable Pacemaker Pulse Generator
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…
With Cardiac Resynchronization (Crt-P) Implantable Pacemaker Pulse Generator
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…
With Cardiac Resynchronization (Crt-P) Implantable Pacemaker Pulse Generator
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…
With Cardiac Resynchronization (Crt-P) Implantable Pacemaker Pulse Generator
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…
With Cardiac Resynchronization (Crt-P) Implantable Pacemaker Pulse Generator
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…
With Cardiac Resynchronization (Crt-P) Implantable Pacemaker Pulse Generator
Process design
Boston Scientific Corp…MNJan 22, 2025
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)”). Informational only — verify against the FDA before acting.