Medtronic MiniMed recalls Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4 system

Recall date

November 21, 2022

Source

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

Recall number

Z-0776-2023

FDA classification

Class II

Brand / firm

Medtronic MiniMed

Sold / distributed

OUS: Austria, Belgium, Chile, Colombia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Kazakhstan, Kuwait, Luxembourg, Moldova, Republic of, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Romania, Saudi Arabia, Serb…

Why it was recalled

An app, part of a continuous glucose monitoring system, for use with smartphone devices may automatically log out from CareLink, then the app is not able to upload data. When logged out, linked care partners will not receive SMS notifications (could result in hypoglycemia or hyperglycemia), and sensor glucose values will also not be sent to the InPen app.

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

What was recalled

Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4 system