ST. Jude Medical, Inc. (crm-kista)
FDA adverse event reports naming ST. Jude Medical, Inc. (crm-kista) as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: ST. JUDE MEDICAL, INC. (CRM-KISTA).
- Total reports
- 5,323
- Deaths
- 86
- Injuries
- 2,570
- Malfunctions
- 2,667
Reports per year
3,43715
1,88616
Source: FDA adverse event reports by year received, 2015–2016. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Permanent Defibrillator ElectrodesNVY1,663
- Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker ElectrodesNVN914
- Implantable Cardioverter Defibrillator (Non-Crt)LWS824
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)NIK799
- Implantable Pulse Generator, Pacemaker (Non-Crt)LWP489
- Drug Eluting Permanent Left Ventricular (Lv) Pacemaker ElectrodeOJX442
- Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)MXC83
- Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)NKE71
- Catheter, PercutaneousDQY19
- Transmitters And Receivers, Physiological Signal, RadiofrequencyDRG9
Recent recalls
No recalls listed in the FDA device recall database for this entry.
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