Medtronic Puerto Rico Operations Co.
FDA adverse event reports naming Medtronic Puerto Rico Operations Co. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: Medtronic Puerto Rico Operations Co..
- Total reports
- 29,372
- Deaths
- 17
- Injuries
- 3,344
- Malfunctions
- 26,002
Reports per year
125
29,37126
Source: FDA adverse event reports by year received, 2025–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Top device categories
- Automated Insulin Dosing Device System, Single Hormonal ControlOZP17,945
- Alternate Controller Enabled Insulin Infusion PumpQFG6,156
- Interoperable Automated Glycemic ControllerQJI2,080
- Pump, Infusion, Insulin, To Be Used With Invasive Glucose SensorOYC1,291
- Pump, Infusion, InsulinLZG816
- Pump, InfusionFRN415
- Interoperable Automated Glycemic Controller, Insulin SuspendQJS245
- Automated Insulin Dosing , Threshold SuspendOZO210
- Calculator, Drug DoseNDC146
- Sensor, Glucose, Invasive, Component Of Automated Insulin Delivery SystemSFI56
Recent recalls
No recalls listed in the FDA device recall database for this entry.
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