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
- 1,999
- Deaths
- 48
- Injuries
- 809
- Malfunctions
- 1,137
Reports per year
40109
10811
37712
1513
45114
1015
916
717
1118
220
121
122
124
725
126
Source: FDA adverse event reports by year received, 2009–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Pump, Infusion, Insulin, To Be Used With Invasive Glucose SensorOYC566
- Stimulator, Spinal-Cord, Totally Implanted For Pain ReliefLGW391
- Pump, Infusion, Implanted, ProgrammableLKK288
- Stimulator, Electrical, Implanted, For Parkinsonian TremorMHY168
- Stimulator, Electrical, Implantable, For IncontinenceEZW131
- Automated Insulin Dosing , Threshold SuspendOZO112
- Pump, InfusionFRN100
- Sensor, Glucose, InvasiveMDS99
- Pump, Infusion, InsulinLZG59
- Permanent Pacemaker ElectrodeDTB33
Recent recalls
No recalls listed in the FDA device recall database for this entry.
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