MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android)
FDA device recall Z-2778-2026 · posted 2026-07-23 · Open, Classified
Recall details
- Recalling firm
- Medtronic MiniMed, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- NDC
- Quantity affected
- 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,
- Date initiated
- 2026-06-16
- Date posted
- 2026-07-23
- Location
- Northridge, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MiniMed Go App (K253512) | Medtronic Minimed | 2026-01-08 |