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
- 13,846
- Deaths
- 244
- Injuries
- 4,849
- Malfunctions
- 8,507
Reports per year
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
- Permanent Pacemaker ElectrodeDTB3,976
- 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-GeneratorDXY355
- 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
- 2026-08-18Open, ClassifiedProcess design
MiniMed 640G Insulin Pump, Model: MMT-1711, MMT-1712;
Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or under-delivery, potentially causing hypoglycemia, hyperglycemia, or diabetic ketoacidosis.
- 2026-08-18Open, ClassifiedProcess design
MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782;
Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or under-delivery, potentially causing hypoglycemia, hyperglycemia, or diabetic ketoacidosis.
- 2026-08-18Open, ClassifiedProcess design
MiniMed 780G Insulin Pump, Model: MMT-1885CLW, MMT-1886CLW
Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or under-delivery, potentially causing hypoglycemia, hyperglycemia, or diabetic ketoacidosis.
- 2026-07-27Open, ClassifiedUnder Investigation by firm
EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77422
Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures.
- 2026-07-27Open, ClassifiedUnder Investigation by firm
EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77522
Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures.
- 2026-07-27Open, ClassifiedUnder Investigation by firm
EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77622
Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures.
- 2026-07-27Open, ClassifiedUnder Investigation by firm
EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77722
Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures.
- 2026-07-27Open, ClassifiedUnder Investigation by firm
EOPA 3D Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78222
Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures.
- 2026-07-27Open, ClassifiedUnder Investigation by firm
EOPA 3D Arterial Cannula 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78322
Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures.
- 2026-07-23Open, ClassifiedSoftware design
MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android)
For MiniMed Go app version 1.0.0 and 1.1.0, when the Set day and night is turned OFF and missed dose or Correct high glucose alerts are enabled, the associated alerts will not be triggered during the nighttime. This could result in missed rapid-acting insulin doses without the user s knowledge, and may lead to delayed therapy and an increased risk of hyperglycemia.
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