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
- 74,563
- Deaths
- 700
- Injuries
- 30,764
- Malfunctions
- 42,795
Reports per year
1,94212
2,97213
3,46314
3,70115
4,19116
4,44217
4,40918
5,29219
5,08620
6,30021
6,15322
6,10223
6,27224
6,37925
3,45326
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Top device categories
- Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker ElectrodesNVN26,435
- Permanent Defibrillator ElectrodesNVY18,786
- Implantable Cardioverter Defibrillator (Non-Crt)LWS7,614
- Pulse Generator, Permanent, ImplantableNVZ6,596
- Defibrillator, Implantable, Dual-ChamberMRM4,024
- Drug Eluting Permanent Left Ventricular (Lv) Pacemaker ElectrodeOJX3,894
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)NIK2,615
- Permanent Pacemaker ElectrodeDTB1,826
- Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)MXD1,467
- Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)NKE598
Recent recalls
No recalls listed in the FDA device recall database for this entry.
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