[Recalled] Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4 system — An app, part of a continuous glucose monitoring system, for use with smartphone… | FDA 2022-11-21

The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: 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.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Medtronic MiniMed

• Medtronic MiniMed Paradigm Insulin pump, model number MMT-723 — Class II
• Medtronic MiniMed Paradigm Insulin pump, model number MMT-523K — Class II
• Medtronic MiniMed Paradigm Insulin pump, model numbers MMT 515 and MMT-715 — Class II
• MiniMed Insulin Pump, model # MMT-508 — Class II
• Medtronic MiniMed Paradigm Insulin pump, model number MMT-522 — Class II
• MiniMed 640G Insulin Pump (O.U.S. Version) — Class II

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.