Recall Z-0265-2027 ยท NDC Calculator, Drug Dose
Medtronic MiniMed, Inc.
Generic Name: MiniMed Go App Generic Name: MiniMed Go App Model/Catalog Number: MMT-8600 (iOS), MMT-8601 (Android) Software Version: Software version 1.2.1 Product Description: The MiniMed Go app for iOS or MiniMed Go app for Android is compatible with the following components: " Simplera sensor " Instinct sensor " InPen smart insulin pen " Apple Watch [Optional] Continuous glucose monitoring (CG
| Date | Oct 22, 2026 (initiated Sep 2, 2026) |
| Status | Open, Classified |
| Reason | A software defect in which existing users who had previously configured and enabled the long-acting dose reminder feature in version 1.2.0 or earlier experienced failure of the long-acting dose reminder after updating their app to version 1.2.1. The long-acting dose reminder is an optional feature that, when enabled, triggers a notification at the scheduled time to remind users to take their long-acting insulin dose. The issue was caused by a type cast exception during database migration that occurs upon app update to version 1.2.1 causing a silent failure that prevented the creation of new al |
| Root cause | Software design |
| Action | On 09/14/2026, customers were contacted via SMS, emailed or via an "URGENT MEDICAL DEVICE CORRECTION" Letter informing them that, an issue was identified with the MiniMed Go app in which the long-acting dose reminders were not being delivered after the app was updated to version 1.2.1. Actions required: Users of MiniMed Go app software versions 1.2.1 should update to version 1.2.2 or higher as soon as possible to resolve this issue. This update will ensure enabled long-acting reminders are delivered as expected. For iOS Users: To confirm the latest app version on your iOS device, follow the s |
| Quantity | 623 |
| Distribution | Worldwide - U.S. Nationwide distribution in the states of AL, CA, CT, FL, LA, MA, MD, NY, OH, PA, and TX. The countries of Austria, Belgium, Denmark, Finland, Germany, Iceland, Italy, Norway, Spain, Sweden, Switzerland, United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K253512 | MiniMed Go App Medtronic Minimed, Jan 8, 2026 |