FDA-Device2020-04-01Class II
Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
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
38
Manufactured in
18000 Devonshire St, N/A, Northridge, CA, United States
Products
Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1589-2020Don't want to check this manually?
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