Biotronik SE & Co. Kg
FDA adverse event reports naming Biotronik SE & Co. Kg as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: BIOTRONIK SE & CO. KG.
- Total reports
- 74,318
- Deaths
- 700
- Injuries
- 30,541
- Malfunctions
- 42,773
Reports per year
1,94212
2,97213
3,46314
3,70115
4,19116
4,44217
4,40918
5,29319
5,08620
6,30021
6,15322
6,10223
6,27224
6,37925
3,20726
Source: FDA adverse event reports by year received, 2012–2026. 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 ElectrodesNVN26,356
- Permanent Defibrillator ElectrodesNVY18,726
- Implantable Cardioverter Defibrillator (Non-Crt)LWS7,581
- Pulse Generator, Permanent, ImplantableNVZ6,573
- Defibrillator, Implantable, Dual-ChamberMRM4,006
- Drug Eluting Permanent Left Ventricular (Lv) Pacemaker ElectrodeOJX3,885
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)NIK2,601
- Permanent Pacemaker ElectrodeDTB1,824
- Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)MXD1,463
- Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)NKE597
Recent recalls
No recalls listed in the FDA device recall database for this entry.
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