Medtronic
FDA adverse event reports naming Medtronic as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: MEDTRONIC.
- Total reports
- 13,839
- Deaths
- 244
- Injuries
- 4,846
- Malfunctions
- 8,503
Reports per year
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
- Permanent Pacemaker ElectrodeDTB3,974
- Implantable Cardioverter Defibrillator (Non-Crt)LWS2,481
- Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker ElectrodesNVN1,934
- Permanent Defibrillator ElectrodesNVY1,237
- Drug Eluting Permanent Left Ventricular (Lv) Pacemaker ElectrodeOJX596
- Implantable Pacemaker Pulse-GeneratorDXY354
- Pump, Infusion, Implanted, ProgrammableLKK261
- Implantable Pulse Generator, Pacemaker (Non-Crt)LWP249
- Pulse Generator, Permanent, ImplantableNVZ207
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)NIK179
Recent recalls
- 2026-07-15Open, ClassifiedPackaging
Medtronic DLP One-Piece Pediatric Arterial Cannula, Product Number/CFN 77010; Cardiopulmonary bypass vascular cannula
Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.
- 2026-07-15Open, ClassifiedPackaging
Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardiopulmonary bypass vascular cannula
Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.
- 2026-07-08Open, ClassifiedSoftware design
MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896
A software anomaly can occur when the pump is paired with the Instinct sensor. Under certain circumstances, the pump unexpectedly stops delivering insulin and displays two error messages back-to-back: Pump Error 53 followed immediately by Pump Error 23. Insulin delivery will stop which may lead to delayed therapy and an increased risk of hyperglycemia or diabetic ketoacidosis (DKA).
- 2026-07-02Open, ClassifiedProcess control
Medtronic Harmony Delivery Catheter System
Devices containing inner shaft assemblies from specific manufacturing lots may have an increased potential for distal tip detachment from the delivery system under certain procedural or anatomical conditions due to a manufacturing issue.
- 2026-06-24Open, ClassifiedUnder Investigation by firm
Octopus Evolution Tissue Stabilizer, Model TS2000
During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.
- 2026-06-24Open, ClassifiedUnder Investigation by firm
Octopus Evolution AS Tissue Stabilizer, Model TS2500
During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.
- 2026-06-24Open, ClassifiedUnder Investigation by firm
Octopus 4 Tissue Stabilizer, Model 29400
During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.
- 2026-06-15Open, ClassifiedUnder Investigation by firm
Medtronic O-arm O2 Imaging System. Model Number: BI70002000.
Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.
- 2026-05-28Open, ClassifiedUnder Investigation by firm
Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for parkinsonian tremor
A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.
- 2026-05-28Open, ClassifiedUnder Investigation by firm
Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Stimulator, electrical, implanted, for parkinsonian tremor
A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.
Monitor Medtronic 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.