Z-1588-2020 Class II Ongoing

Recalled by Medtronic MiniMed — Northridge, CA

Recall Details

Product Type
Devices
Report Date
April 1, 2020
Initiation Date
June 27, 2019
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
225,498

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.

Distribution Pattern

US nationwide distribution including Puerto Rico.

Code Information

All software Versions