Medtronic Europe Sarl
FDA adverse event reports naming Medtronic Europe Sarl as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: MEDTRONIC EUROPE SARL.
- Total reports
- 45,471
- Deaths
- 600
- Injuries
- 17,538
- Malfunctions
- 27,311
Reports per year
1212
1313
1514
3315
21116
4,09717
4,57018
4,41119
4,35820
4,79421
4,09622
4,79823
5,15924
5,31225
2,99126
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
- Detector And Alarm, ArrhythmiaDSI12,365
- Implantable Cardioverter Defibrillator (Non-Crt)LWS12,118
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)NIK11,603
- Pulse Generator, Permanent, ImplantableNVZ5,392
- Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)NKE2,160
- Stimulator, Electrical, Implanted, For Parkinsonian TremorMHY708
- Stimulator, Spinal-Cord, Totally Implanted For Pain ReliefLGW364
- Implantable Pulse Generator, Pacemaker (Non-Crt)LWP253
- Implantable Pacemaker Pulse-GeneratorDXY233
- Stimulator, Electrical, Implantable, For IncontinenceEZW115
Recent recalls
No recalls listed in the FDA device recall database for this entry.
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