FDA Medical Device Recalls (openFDA)
Medtronic MiniMed: Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4 system
- Recall number
- Z-0776-2023
- Recalling firm
- Medtronic MiniMed
- Product
- Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4 system
- Status
- Open, Classified
- Initiated
- 2022-11-21
- Posted
- 2023-01-01
- Terminated
- not on file
- 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.
- 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 rs.safetyinformation@medtronic.com For questions, contact our 24-Hour Technical Support line at 1-800-646-4633, option 1.
- Quantity
- 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
- Lot, serial or model codes
- App Version 1.3.0
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MDS
- Firm FEI
- 3003166194
- Firm city
- Northridge
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28