ST. Jude Medical, Cardiac Rhythm Management Divisi
FDA adverse event reports naming ST. Jude Medical, Cardiac Rhythm Management Divisi as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI.
- Total reports
- 1,430
- Deaths
- 5
- Injuries
- 315
- Malfunctions
- 1,108
Reports per year
1,42914
122
Source: FDA adverse event reports by year received, 2014–2022. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Implantable Pacemaker Pulse-GeneratorDXY552
- Permanent Pacemaker ElectrodeDTB373
- Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker ElectrodesNVN205
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)NIK101
- Implantable Pulse Generator, Pacemaker (Non-Crt)LWP86
- Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)MXC60
- Drug Eluting Permanent Left Ventricular (Lv) Pacemaker ElectrodeOJX26
- Sucker, Cardiotomy Return, Cardiopulmonary BypassDTS14
- Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)NKE8
- Catheter, PercutaneousDQY1
Recent recalls
No recalls listed in the FDA device recall database for this entry.
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