FDA Device recall Z-0776-2023
Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4 system
- FDA Device
- Class II
- ongoing
- Published 2023-01-11
On 2023-01-11 the FDA classified a Class II recall of Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4 system by Medtronic Minimed, citing 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 logg….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0776-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-11-21 |
| Published | 2023-01-11 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic Minimed |
| Distribution | n/a |
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.
Identifiers
| code_info | App Version 1.3.0 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Other recalls by Medtronic Minimed
- Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin Pump Model/Catalog Numbers: MMT-8062
FDA Device · Class II · 2026-10-14 · Medtronic Minimed - MiniMed 640G Insulin Pump, Model: MMT-1711, MMT-1712
FDA Device · Class II · 2026-08-26 · Medtronic Minimed - MiniMed 780G Insulin Pump, Model: MMT-1885CLW, MMT-1886CLW
FDA Device · Class II · 2026-08-26 · Medtronic Minimed - MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782
FDA Device · Class II · 2026-08-26 · Medtronic Minimed - MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android)
FDA Device · Class II · 2026-07-29 · Medtronic Minimed
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0776-2023%22
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