Biotronik Gmbh AND Co.
FDA adverse event reports naming Biotronik Gmbh AND Co. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: BIOTRONIK GMBH AND CO..
- Total reports
- 2,447
- Deaths
- 57
- Injuries
- 1,726
- Malfunctions
- 501
Reports per year
304
6405
14406
34407
1,10108
79009
110
Source: FDA adverse event reports by year received, 2004–2010. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Permanent Pacemaker ElectrodeDTB1,557
- Implantable Cardioverter Defibrillator (Non-Crt)LWS456
- Implantable Pacemaker Pulse-GeneratorDXY276
- Defibrillator, Implantable, Dual-ChamberMRM109
- Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)NKE13
- Pulse Generator, Permanent, ImplantableNVZ11
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)NIK7
- Wire, Guide, CatheterDQX3
- Pulse-Generator, Pacemaker, ExternalDTE3
- Programmer, PacemakerKRG3
Recent recalls
No recalls listed in the FDA device recall database for this entry.
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