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
- 1,990,274
- Deaths
- 5,768
- Injuries
- 395,722
- Malfunctions
- 1,588,572
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
176,66825
103,10426
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
- Automated Insulin Dosing Device System, Single Hormonal ControlOZP799,875
- Pump, Infusion, Insulin, To Be Used With Invasive Glucose SensorOYC596,812
- Automated Insulin Dosing , Threshold SuspendOZO263,972
- Stimulator, Spinal-Cord, Totally Implanted For Pain ReliefLGW78,538
- Pump, Infusion, Implanted, ProgrammableLKK47,417
- Pump, InfusionFRN47,054
- Stimulator, Electrical, Implantable, For IncontinenceEZW44,526
- Pump, Infusion, InsulinLZG36,559
- Stimulator, Electrical, Implanted, For Parkinsonian TremorMHY18,471
- Pulse Generator, Permanent, ImplantableNVZ15,280
Recent recalls
No recalls listed in the FDA device recall database for this entry.
Monitor Medtronic Puerto Rico Operations Co. 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.