ST. Jude Medical, Inc.(crm-sunnyvale)
FDA adverse event reports naming ST. Jude Medical, Inc.(crm-sunnyvale) as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE).
- Total reports
- 53,055
- Deaths
- 4,124
- Injuries
- 26,029
- Malfunctions
- 22,899
Reports per year
113
614
6,34615
14,94316
10,26317
7,15118
9,76219
4,56520
721
922
123
124
Source: FDA adverse event reports by year received, 2013–2024. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Permanent Defibrillator ElectrodesNVY12,410
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)NIK12,328
- Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker ElectrodesNVN9,582
- Implantable Cardioverter Defibrillator (Non-Crt)LWS9,579
- Pulse Generator, Permanent, ImplantableNVZ2,533
- Drug Eluting Permanent Left Ventricular (Lv) Pacemaker ElectrodeOJX1,974
- Implantable Pulse Generator, Pacemaker (Non-Crt)LWP1,936
- Implantable Pacemaker Pulse-GeneratorDXY1,055
- Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)MXC1,037
- Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)NKE234
Recent recalls
No recalls listed in the FDA device recall database for this entry.
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