Z-0776-2023Class II

Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4 system

Name: Z-0776-2023 Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4 system
Creator: Medtronic MiniMed
Published: 2022-11-21
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2022-11-21 / Open, Classified / root cause: software

FDA source

Medtronic MiniMed began a recall of Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4 system on 2022-11-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0776-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-11-21
Posted: 2023-01-01
Recalling firm: Medtronic, Inc.
Product: Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4 system
Product code: MDS Sensor, Glucose, Invasive
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.
Root cause tag: software
FDA root cause: Software change control
Action: On 11/21/22, correction notices were sent to patients, care partners, and healthcare providers. The following actions were requested of users: iOS/Android Users: 1) Verify what version of the app you are running by taking the following steps: a) On the home screen, navigate to the settings menu on the upper left corner b) Select "Help" c) Confirm "Version" 2) If you are not running version 1.3.0, no action is necessary 3) If you have version 1.3.0, update to the latest app version currently available in the App Store (1.3.1) by following these steps: iOS Users: a) Open the App Store app. b) Tap your profile icon at the top of the screen. c) Scroll to see pending updates. d) Tap update next to the mobile app icon to update the app. Android Users: a) Open the Google Play Store app. b) Tap Menu and then Manage apps & devices. c) Apps with an update available are labelled "Update available". You can also search for a specific app. d) Tap Update. Once you update to version 1.3.1 and log in to the Guardian App all your past data from version 1.3.0 will remain available and visible. It is not recommended or necessary to uninstall the current version of the app from your phone before installing the new version 1.3.1. If you choose to do so, your local data will not able available in the app and you will be prompted to pair your transmitter. Complete and return the Customer Confirmation Form. Form can be returned to [email protected] For questions, contact our 24-Hour Technical Support line at 1-800-646-4633, option 1.
Quantity in commerce: 3235
Distribution: OUS: Austria, Belgium, Chile, Colombia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Kazakhstan, Kuwait, Luxembourg, Moldova, Republic of, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Romania, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom
Product codes and lots: App Version 1.3.0

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0776-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0776-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-11	2022-12-31

Product code MDS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)