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Medtronic MiniMed recalls MiniMed Paradigm 512 Insulin pump
Recalled April 1, 2020 · FDA recall Z-1583-2020 · Medtronic MiniMed
Hazard
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. · FDA Class II
Units
34,777
Sold at
US nationwide distribution including Puerto Rico.
Description
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.
Product
MiniMed Paradigm 512 Insulin pump
Manufacturer(s)
Medtronic MiniMed
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →