PlainRecalls
FDA Devices Moderate Class II Ongoing

Medtronic MiniMed Paradigm Insulin pump, model number MMT-722

Reported: April 1, 2020 Initiated: June 27, 2019 #Z-1588-2020

Product Description

Medtronic MiniMed Paradigm Insulin pump, model number MMT-722

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.

Details

Recalling Firm
Medtronic MiniMed
Units Affected
225,498
Distribution
US nationwide distribution including Puerto Rico.
Location
Northridge, CA

Frequently Asked Questions

What product was recalled?
Medtronic MiniMed Paradigm Insulin pump, model number MMT-722. Recalled by Medtronic MiniMed. Units affected: 225,498.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 1, 2020. Severity: Moderate. Recall number: Z-1588-2020.