Z-0265-2027Class II

Generic Name: MiniMed Go App Generic Name: MiniMed Go App Model/Catalog Number: MMT-8600 (iOS), MMT-8601...

Name: Z-0265-2027 Generic Name: MiniMed Go App Generic Name: MiniMed Go App Model/Catalog Number: MMT-8600 (iOS), MMT-8601...
Creator: Medtronic MiniMed, Inc.
Published: 2026-09-02
License: https://open.fda.gov/license/

Medtronic MiniMed, Inc. / initiated 2026-09-02 / Open, Classified

FDA source

Recall record

Recall number: Z-0265-2027
Classification: Class II
Status: Open, Classified
Initiated: 2026-09-02
Posted: 2026-10-22
Recalling firm: Medtronic MiniMed, Inc.
Product: 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
Product code: NDC Calculator, Drug Dose
Reason for recall: 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.
FDA 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 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 theMiniMed Go app. 4. Tap Update next to the MiniMed Go app icon. For Questions or assistance - call the Medtronic MiniMed 24-Hour Technical Support line at 1-800-646-4633, option 1.
Quantity in commerce: 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.
Product codes and lots: Lot Code: GTIN for MMT-8600, iOS: 00199150038978 GTIN for MMT-8601, Android: 00199150038985 UDI for MMT-8600, iOS: 00199150038978 UDI for MMT-8601, Android: 00199150038985 Software version 1.2.1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0265-2027
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0265-2027	Class II	Ongoing	Voluntary: Firm initiated	2026-10-28	2026-10-22

Product code NDC

K253512Class IIMiniMed Go AppMedtronic Minimed / cleared 2026-01-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-28, the FDA export date for this dataset. Page last changed 2026-10-30. View this recall on fda.gov (opens on fda.gov)