medical Class II Updated 2020-04-01

Medtronic MiniMed recalls MiniMed Paradigm Model 511 Insulin Pump

Recalled Product

MiniMed Paradigm Model 511 Insulin Pump

Hazard / Issue

The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An unauthorized person could potentially connect wirelessly to a nearby insulin pump to change settings and control insulin delivery.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All Software Versions
View official government recall

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