Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0776-2023 — Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4 system

U.S. FDA — Device Enforcement · United States · 2022-11-21 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0776-2023
Date of alert
2022-11-21
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Medtronic MiniMed
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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