Recall Z-1595-2020— Medtronic MiniMed

Class II · Ongoing

Class II FDA medical device recall by Medtronic MiniMed, initiated 2019-06-27. FDA's recall record names no specific 510(k) clearance for this event. Product: Medtronic MiniMed Paradigm Veo Insulin pump, model numbers MMT-554 and MMT-754. Reason: 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..

Recalling firm
Medtronic MiniMed
Classification
Class II
Status
Ongoing
Initiated
2019-06-27
Firm location
Northridge, CA, United States

Product description

Medtronic MiniMed Paradigm Veo Insulin pump, model numbers MMT-554 and MMT-754

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.