FDA Medical Device Recalls (openFDA)
Medtronic MiniMed, Inc.: MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android)
- Recall number
- Z-2778-2026
- Recalling firm
- Medtronic MiniMed, Inc.
- Product
- MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android)
- Status
- Open, Classified
- Initiated
- 2026-06-16
- Posted
- 2026-07-23
- Terminated
- not on file
- Reason
- For MiniMed Go app version 1.0.0 and 1.1.0, when the Set day and night is turned OFF and missed dose or Correct high glucose alerts are enabled, the associated alerts will not be triggered during the nighttime. This could result in missed rapid-acting insulin doses without the user s knowledge, and may lead to delayed therapy and an increased risk of hyperglycemia.
- Root cause
- Software design
- Action
- On 6/16/2026 In-App Push Notifications were sent to customers entitled, Important Field Safety Corrective Action required on your MiniMed Go app. informing them a software upgrade is available to ensure important nighttime notifications are received. Correction notices were also emailed to customers informing them to update to version 1.2.0 or higher. For iOS Users: To confirm the latest app version on your iOS device, follow the steps below: 1. Open the App Store. 2. Tap your profile icon at the top of the screen. 3. Scroll to see pending updates. 4. Tap Update next to the MiniMed Go app icon. For Android Users: To confirm the latest app version on your Android device, follow the steps below: 1. Open the Google Play Store. 2. Tap Menu, then select Manage apps & device. 3. Apps with an update available are labeled "Update available." You can also search for the MiniMed Go app. 4. Tap Update next to the MiniMed Go app icon. Acknowledge that you have read and understood the notification by clicking the acknowledgement button or visiting https://www.minimed.com/en-us/safety-notices/notice31-letter If you have further questions or need assistance, please call the firm's 24-Hour Technical Support line at 1-800-646-4633, option 1.
- Quantity
- 3,465
- Distribution
- Worldwide - US Nationwide distribution in the states and territories of PR, OH, WA, IL, NC, PA, VA, MN, ID, CA, UT, MI, NJ, MS, SC, CO, AZ, OR, AR, MO, TX, AL, FL, NY, IN, TN, IA, WI, MA, LA, OK, GA, KS, NM, CT, KY, NH, NV, MD and the countries of Australia, Switzerland, Germany, Denmark, Spain, Finland, Iceland, Norway, Sweden.
- Lot, serial or model codes
- Model/UDI-DI: MMT-8600/00199150038978(10)1.1.0, MMT-8601/00199150038985(10)1.1.0 Software Versions: 1.0.0, 1.1.0
- 510(k) numbers
- ["K253512"]
- PMA numbers
- not on file
- Product code
- NDC
- 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