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
- 1,974,488
- Deaths
- 5,757
- Injuries
- 391,244
- Malfunctions
- 1,577,276
Reports per year
6,45312
11,65913
47,63014
110,06415
96,20416
128,84217
147,21418
184,08119
185,54920
150,26721
276,89822
183,69523
173,16224
176,66725
87,32026
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
- Automated Insulin Dosing Device System, Single Hormonal ControlOZP793,969
- Pump, Infusion, Insulin, To Be Used With Invasive Glucose SensorOYC596,383
- Automated Insulin Dosing , Threshold SuspendOZO263,900
- Stimulator, Spinal-Cord, Totally Implanted For Pain ReliefLGW76,496
- Pump, InfusionFRN46,893
- Pump, Infusion, Implanted, ProgrammableLKK46,020
- Stimulator, Electrical, Implantable, For IncontinenceEZW43,222
- Pump, Infusion, InsulinLZG36,278
- Stimulator, Electrical, Implanted, For Parkinsonian TremorMHY18,108
- Pulse Generator, Permanent, ImplantableNVZ15,104
Recent recalls
No recalls listed in the FDA device recall database for this entry.
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