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
- 45,125
- Deaths
- 597
- Injuries
- 17,331
- Malfunctions
- 27,175
Reports per year
1212
1313
1514
3315
21116
4,09717
4,57018
4,41119
4,35820
4,79421
4,09622
4,79723
5,15924
5,31225
2,64426
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
- Detector And Alarm, ArrhythmiaDSI12,360
- Implantable Cardioverter Defibrillator (Non-Crt)LWS11,964
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)NIK11,484
- Pulse Generator, Permanent, ImplantableNVZ5,362
- Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)NKE2,123
- Stimulator, Electrical, Implanted, For Parkinsonian TremorMHY707
- Stimulator, Spinal-Cord, Totally Implanted For Pain ReliefLGW365
- Implantable Pulse Generator, Pacemaker (Non-Crt)LWP253
- Implantable Pacemaker Pulse-GeneratorDXY233
- Stimulator, Electrical, Implantable, For IncontinenceEZW116
Recent recalls
No recalls listed in the FDA device recall database for this entry.
Monitor Medtronic Europe Sarl 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.