FDA recall Z-1585-2020

Medtronic MiniMed · Class II · device

Product

Medtronic MiniMed Paradigm Insulin pump, model number MMT-712E

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.

Distribution

US nationwide distribution including Puerto Rico.

Key facts

Status
Ongoing
Initiation date
2019-06-27
Report date
2020-04-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Northridge, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1585-2020