ST. Jude Medical, Inc.(crm-sylmar)
FDA adverse event reports naming ST. Jude Medical, Inc.(crm-sylmar) as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: ST. JUDE MEDICAL, INC.(CRM-SYLMAR).
- Total reports
- 193,385
- Deaths
- 5,209
- Injuries
- 94,835
- Malfunctions
- 93,338
Reports per year
112
5,63115
7,46116
11,28017
16,74518
14,79219
16,37220
23,22021
24,92122
24,01923
22,02524
22,33325
4,58526
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker ElectrodesNVN66,520
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)NIK34,183
- Permanent Defibrillator ElectrodesNVY23,806
- Implantable Pulse Generator, Pacemaker (Non-Crt)LWP20,559
- Pulse Generator, Permanent, ImplantableNVZ16,023
- Implantable Cardioverter Defibrillator (Non-Crt)LWS9,917
- Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)MXC6,360
- Drug Eluting Permanent Left Ventricular (Lv) Pacemaker ElectrodeOJX5,839
- Leadless PacemakerPNJ3,948
- Implantable Pacemaker Pulse-GeneratorDXY2,929
Recent recalls
No recalls listed in the FDA device recall database for this entry.
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