Use caution Medical device recall · FDA · Published November 21, 2022

Medtronic Guardian App Recalls: Data Not Uploading Risk

Medtronic MiniMed recalls Guardian iOS and Android apps (v1.3.0) due to potential failure to upload glucose data, risking hypoglycemia or hyperglycemia. Affected users should check app version.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0776-2023Medical device Medtronic MiniMed ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmMedtronic MiniMed18000 Devonshire St · Northridge, CA 91325-1219

✎ GovInfoNow plain-language explainer

Medtronic MiniMed is recalling its Guardian iOS and Android apps (version 1.3.0) because they may stop sending glucose data to your phone or other devices. This could lead to missing critical health information, increasing the risk of dangerous blood sugar levels. Read more at govinfonow.com/recall/59305-medtronic-guardian-app-recalls-data-not-uploading-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/59305-medtronic-guardian-app-recalls-data-not-uploading-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0776-2023

Cite this page

“Medtronic Guardian App Recalls: Data Not Uploading Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59305-medtronic-guardian-app-recalls-data-not-uploading-risk. Based on FDA recall #Z-0776-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0776-2023%22&limit=1).

The Food and Drug Administration announced on November 21, 2022, that Medtronic MiniMed is recalling the Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201). The apps may automatically log out from CareLink, preventing data uploads and SMS notifications to care partners. This issue could result in hypoglycemia or hyperglycemia.

How to tell if you have it

Brand: Medtronic MiniMed
Product: Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201)
App Version: 1.3.0
Units affected: 3,235

The hazard

According to the FDA, the apps may automatically log out from CareLink, after which they cannot upload data. When logged out, linked care partners will not receive SMS notifications and sensor glucose values will not be sent to the InPen app. The agency states this could result in hypoglycemia or hyperglycemia.

Context

GovInfoNow's records show Medtronic MiniMed has issued five other recalls since June 27, 2019. Other recent recalls of similar products include Medtronic MiniMed 600 Series Insulin Pumps (September 20, 2022), Medtronic MiniMed 670G Insulin Pump (May 23, 2022), and Medtronic MiniMed 630G/670G Insulin Pumps (January 27, 2022). Other recent recalls of similar products include Medtronic MiniMed Go App Version 1.0.0/1.1.0 (June 16, 2026) and Dexcom G7 CGM App (April 14, 2026).

How to tell if you have this one

Check if you have the Guardian iOS app (MMT-8200) or Android app (MMT-8201) version 1.3.0. The app is part of the Guardian 4 system for continuous glucose monitoring.

Brand
Medtronic MiniMed
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check App Version
Look for the app version number in your device settings or app store profile.
Update App
Download the latest app version from the official app store to fix the issue.

How this recall unfolded

Recall timeline

FDA published this recall 51 days after the firm started it.

Nov 21, 2022Firm started the recall
Dec 31, 2022FDA classified it Class II
Jan 11, 2023Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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More Medtronic MiniMed recalls

Link to this recall

<a href="https://govinfonow.com/recall/59305-medtronic-guardian-app-recalls-data-not-uploading-risk">Medtronic Guardian App Recalls: Data Not Uploading Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0776-2023 (November 21, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0776-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.