FDA-Device2026-10-22Class IIPROCESSING DEFECT

Medtronic MiniMed Go App version 1.2.1 recalled for failed insulin dose reminders

OTHERNationwide distributionMedical devices

What this means

A software bug in MiniMed Go version 1.2.1 broke the long-acting insulin dose reminder feature for users who had it enabled in earlier versions. When users updated the app, the reminder stopped working silently—without any alert to the user. This could cause users to miss or delay insulin doses, or accidentally take a double dose if they're unsure whether they already dosed.

If you use MiniMed Go and have the long-acting dose reminder enabled, manually check your insulin schedule until Medtronic releases a fix.
Do not rely on the app reminder to alert you to take your long-acting insulin dose.
Check the Apple App Store or Google Play Store for an updated version of MiniMed Go.
Contact Medtronic if you need additional guidance on managing your insulin doses safely.

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The agency's original wording

Hazard

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 alerts. Failure to receive the long-acting dose reminder may result in missed or delayed insulin doses, potentially leading to hyperglycemia. Conversely, if users are uncertain whether they took their dose due to the missing reminder, inadvertent duplicate dosing may occur, potentially resulting in hypoglycemia.

Intended for

Adults

Illnesses reported

None reported

Sold states

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.

Affected count

623

Manufactured in

18000 Devonshire St, Northridge, California, United States

Products

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 (CGM) is a technology that allows you to continuously view glucose values. The app uses an inserted Simplera sensor CGM or Instinct sensor CGM with Bluetooth¿ wireless technology that converts small amounts of glucose from the interstitial fluid under the skin into an electronic signal. The sensors use that signal to provide sensor glucose (SG) values to the MiniMed Go app on a compatible mobile device. The app also provides alerts based on your SG levels and contains a user interface for entering data such as insulin, meals, exercise, blood glucose (BG) values, and uploading information to the CareLink" Personal website. The app is available to download from the Apple"* App Store"* or the Google Play"* Store. Component: No

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0265-2027

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