Cardiac Pacemakers
FDA adverse event reports naming Cardiac Pacemakers as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: CARDIAC PACEMAKERS.
- Total reports
- 9,857
- Deaths
- 117
- Injuries
- 3,232
- Malfunctions
- 6,507
Reports per year
193
194
796
2,96397
1,58998
82599
1,25200
1,10201
1,08302
37003
11104
6905
12106
16907
19408
Source: FDA adverse event reports by year received, 1993–2008. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Implantable Cardioverter Defibrillator (Non-Crt)LWS6,622
- Implantable Pacemaker Pulse-GeneratorDXY1,848
- Permanent Pacemaker ElectrodeDTB1,214
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)NIK108
- Pacemaker Lead AdaptorDTD18
- Implantable Pulse Generator, Pacemaker (Non-Crt)LWP14
- Wire, Guide, CatheterDQX11
- Programmer, PacemakerKRG7
- Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)NKE7
- Catheter, PercutaneousDQY4
Recent recalls
No recalls listed in the FDA device recall database for this entry.
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