ST. Jude Medical, Inc., Crmd
FDA adverse event reports naming ST. Jude Medical, Inc., Crmd as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: ST. JUDE MEDICAL, INC., CRMD.
- Total reports
- 47,530
- Deaths
- 2,018
- Injuries
- 22,220
- Malfunctions
- 23,259
Reports per year
5598
10699
26700
42101
46702
54303
49404
22005
56106
5,54713
28,49914
10,35015
Source: FDA adverse event reports by year received, 1998–2015. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Implantable Cardioverter Defibrillator (Non-Crt)LWS12,020
- Permanent Defibrillator ElectrodesNVY8,654
- Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker ElectrodesNVN8,145
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)NIK7,327
- Implantable Pacemaker Pulse-GeneratorDXY3,283
- Permanent Pacemaker ElectrodeDTB2,866
- Implantable Pulse Generator, Pacemaker (Non-Crt)LWP2,488
- Drug Eluting Permanent Left Ventricular (Lv) Pacemaker ElectrodeOJX1,977
- Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)MXC422
- Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)NKE175
Recent recalls
No recalls listed in the FDA device recall database for this entry.
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