Abbott Medical (crm-sylmar)
FDA adverse event reports naming Abbott Medical (crm-sylmar) as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: ABBOTT MEDICAL (CRM-SYLMAR).
- Total reports
- 7,136
- Deaths
- 166
- Injuries
- 2,865
- Malfunctions
- 4,105
Reports per year
125
7,13526
Source: FDA adverse event reports by year received, 2025–2026. 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 ElectrodesNVN2,182
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)NIK1,507
- Leadless PacemakerPNJ890
- Permanent Defibrillator ElectrodesNVY814
- Implantable Pulse Generator, Pacemaker (Non-Crt)LWP634
- Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)MXC399
- Pulse Generator, Permanent, ImplantableNVZ276
- Implantable Cardioverter Defibrillator (Non-Crt)LWS246
- Drug Eluting Permanent Left Ventricular (Lv) Pacemaker ElectrodeOJX73
- Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)NKE51
Recent recalls
No recalls listed in the FDA device recall database for this entry.
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