Medtronic S.A.
FDA adverse event reports naming Medtronic S.A. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: MEDTRONIC S.A..
- Total reports
- 10,690
- Deaths
- 446
- Injuries
- 7,924
- Malfunctions
- 2,288
Reports per year
7002
11903
14404
17705
38106
51907
53208
1,00609
2,26910
2,80511
2,56812
1013
814
115
116
Source: FDA adverse event reports by year received, 2002–2016. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Implantable Pacemaker Pulse-GeneratorDXY3,912
- Implantable Cardioverter Defibrillator (Non-Crt)LWS2,859
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)NIK2,180
- Pulse Generator, Permanent, ImplantableNVZ1,493
- Detector And Alarm, ArrhythmiaDSI103
- Implantable Pulse Generator, Pacemaker (Non-Crt)LWP95
- Drug Eluting Permanent Left Ventricular (Lv) Pacemaker ElectrodeOJX26
- Catheter, PercutaneousDQY8
- Permanent Pacemaker ElectrodeDTB6
- Stimulator, Spinal-Cord, Totally Implanted For Pain ReliefLGW4
Recent recalls
No recalls listed in the FDA device recall database for this entry.
Monitor Medtronic S.A. automatically
DeviceWatch watches FDA adverse events and recalls for the products you care about, summarizes clinical narratives with AI and alerts you when a safety signal emerges.