PlainRecalls
FDA Devices Moderate Class II Ongoing

MiniMed Insulin Pump, model # MMT-508

Reported: April 1, 2020 Initiated: June 27, 2019 #Z-1581-2020

Product Description

MiniMed Insulin Pump, model # MMT-508

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
64,174 units
Distribution
US nationwide distribution including Puerto Rico.
Location
Northridge, CA

Frequently Asked Questions

What product was recalled?
MiniMed Insulin Pump, model # MMT-508. Recalled by Medtronic MiniMed. Units affected: 64,174 units.
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-1581-2020.