Medtronic MiniMed recalls Medtronic MiniMed Paradigm Insulin pump, model number MMT-523

Recall date

June 27, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1591-2020

FDA classification

Class II

Brand / firm

Medtronic MiniMed

Sold / distributed

US nationwide distribution including Puerto Rico.

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Medtronic MiniMed Paradigm Insulin pump, model number MMT-523