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 twice in 2026 during FDA reporting-system changes 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.
Monitor Cardiac Pacemakers automatically
DeviceWatch watches FDA adverse events and recalls for the products you care about, summarizes clinical narratives with AI and alerts you when a safety signal emerges.