Recall Z-0776-2023— Medtronic MiniMed
Class II · Ongoing
Class II FDA medical device recall by Medtronic MiniMed, initiated 2022-11-21. FDA's recall record names no specific 510(k) clearance for this event. Product: Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4 system. Reason: 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..
- Recalling firm
- Medtronic MiniMed
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-11-21
- Firm location
- Northridge, CA, United States
Product description
Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4 system
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.