FDA-Device2020-04-01Class II

Medtronic MiniMed Paradigm Insulin pump, model numbers MMT 515 and MMT-715

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.

Sold states
US nationwide distribution including Puerto Rico.
Affected count
73,028
Manufactured in
18000 Devonshire St, N/A, Northridge, CA, United States
Products
Medtronic MiniMed Paradigm Insulin pump, model numbers MMT 515 and MMT-715

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1586-2020

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