Biotronik
FDA adverse event reports naming Biotronik as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: BIOTRONIK.
- Total reports
- 1,629
- Deaths
- 6
- Injuries
- 970
- Malfunctions
- 652
Reports per year
Source: FDA adverse event reports by year received, 2011–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Stimulator, Spinal-Cord, Totally Implanted For Pain ReliefLGW742
- Permanent Defibrillator ElectrodesNVY214
- Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker ElectrodesNVN205
- Permanent Pacemaker ElectrodeDTB152
- Pulse Generator, Permanent, ImplantableNVZ90
- Implantable Cardioverter Defibrillator (Non-Crt)LWS88
- Defibrillator, Implantable, Dual-ChamberMRM45
- Implantable Pacemaker Pulse-GeneratorDXY40
- Drug Eluting Permanent Left Ventricular (Lv) Pacemaker ElectrodeOJX27
- Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)NKE12
Recent recalls
- 2015-08-13TerminatedSoftware Manufacturing/Software Deployment
PSW 1203.U/1, PSW 1301.U, PSW 1307.U, PSW 1403.U, and PSW 1501.U Pacemaker Programmer software. Software approved for use with BIOTRONIK device programmers (trade names: Renamic and ICS 3000). Allows physicians to program devices to pace exclusively in the left ventricle.
Ventricular packing: LV software programming versions for BIOTRONIK CRT-P and CRT-D devices are recalled because they are not approved for use in the US.
- 2008-07-29TerminatedSoftware design
Lumax Cardiac Resyncronization Therapy Defibrillator (CRT-D); Implantable, dual-chamber defibrillator; Model Number: HF-T; Catalog Number 355263; Software Version 603.U; Catalog Model Number 359251; ICS 3000 units are composed of three Catalog/Model Numbers: 349527, 349530, and 355547. The model 349530 is the component which is loaded/updated with software.
Timing Feature Error: An implementation error allows the usage of the V-V timing feature, which is not approved for use in the U.S.
- 2004-07-20TerminatedOther
Tachos DR - Implantable Cardioverter Defibrillator
Potential for device to not deliver full amount of energy
- 2004-07-20TerminatedOther
Tachos DR - Atrial Tx
Potential for device to not deliver full amount of energy
- 2004-07-20TerminatedOther
Tachos ATx
Potential for device to not deliver full amount of energy
- 2004-07-20TerminatedOther
Deikos A+
Potential for device to not deliver full amount of energy
- 2003-10-31TerminatedOther
Belos DR Implantable Cardioverter Defibrillator
Potential extended charge time anomalies.
- 2003-10-31TerminatedOther
Belos DR-T Implantable Cardioverter Defibrillator
Potential extended charge time anomalies.
- 2003-10-31TerminatedOther
Belos VR Implantable Cardioverter Defibrillator
Potential extended charge time anomalies.
- 2003-10-31TerminatedOther
Belos VR-T Implantable Cardioverter Defibrillator
Potential extended charge time anomalies.
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