Pacesetter Inc.
FDA adverse event reports naming Pacesetter Inc. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: PACESETTER INC..
- Total reports
- 1,326
- Deaths
- 5
- Injuries
- 964
- Malfunctions
- 357
Reports per year
196
97897
34498
114
223
Source: FDA adverse event reports by year received, 1996–2023. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Implantable Pacemaker Pulse-GeneratorDXY742
- Permanent Pacemaker ElectrodeDTB574
- Implantable Pulse Generator, Pacemaker (Non-Crt)LWP6
- Implantable Cardioverter Defibrillator (Non-Crt)LWS2
- Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker ElectrodesNVN1
- Permanent Defibrillator ElectrodesNVY1
Recent recalls
No recalls listed in the FDA device recall database for this entry.
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