Sorin CRM
FDA adverse event reports naming Sorin CRM as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: SORIN CRM.
- Total reports
- 1,369
- Deaths
- 25
- Injuries
- 745
- Malfunctions
- 595
Reports per year
Source: FDA adverse event reports by year received, 2010–2021. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Pulse Generator, Permanent, ImplantableNVZ701
- Defibrillator, Implantable, Dual-ChamberMRM492
- Implantable Pacemaker Pulse-GeneratorDXY73
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)NIK41
- Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker ElectrodesNVN29
- Permanent Pacemaker ElectrodeDTB17
- Implantable Pulse Generator, Pacemaker (Non-Crt)LWP12
- Implantable Cardioverter Defibrillator (Non-Crt)LWS2
- Permanent Defibrillator ElectrodesNVY1
- Pulse Generator, External Pacemaker, Dual ChamberOVJ1
Recent recalls
- TerminatedComponent design/selection
Sorin Platinium CRT-D 1711 DF-1, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator
Hardware configuration may lead to overconsumption, followed by loss of pacing and sensing capabilities. The device then cannot identify an arrhythmia that would require defibrillation shock therapy.
- TerminatedComponent design/selection
Sorin Platinium CRT-D 1741 DF-4, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator
Hardware configuration may lead to overconsumption, followed by loss of pacing and sensing capabilities. The device then cannot identify an arrhythmia that would require defibrillation shock therapy.
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