Class II U.S. Food and Drug Administration

Medtronic MiniMed, Inc recall: A software defect in which existing users who had previously configured

Recall published 5 days ago

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.

The hazard: Device malfunction

The notice describes a specific failure mode. That detail is what a clinician needs, because the right action differs sharply between a monitor, an implant and a test kit.

What the notice says: 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…

Why it matters: The device may not perform as intended — a mechanical failure, a software defect, an inaccurate reading, or an alarm that does not sound. For a device someone depends on, the consequence of the failure is usually worse than the failure itself.

Symptoms and when to call a doctor

If the device supports a vital function, do not disable or remove it on your own judgement. Contact the clinician who prescribed or fitted it, and use the back-up arrangement they gave you. Go to an emergency department if the symptoms the device is meant to manage are getting worse, or if an implanted device gives an unexpected alarm or shock.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-0265-2027
Published
October 28, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Medtronic MiniMed, Inc.
Product type
Medical devices
Units affected
623
Distribution
Nationwide
Made in
United States
Lot / code info
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
UPC codes
00199150038978, 00199150038985

Products covered by this recall

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

Check your product

The notice names 3 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00199150038978
  • 00199150038985

Model or item number

On the rating label, the box or the instruction sheet.

  • MMT-8600

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Malfunction

Medtronic MiniMed, Inc. — The notice describes a specific failure mode. That detail is what a clinician needs, because the right action differs sharply between a monitor, an implant and a test kit.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers listed on this page.
  2. Check whether the remedy is a software update, and if so confirm afterwards in the device menu that the version actually changed.
  3. If you are a clinic or facility, quarantine affected stock and record the correction in your recall log.
  4. Report device problems to the FDA through MedWatch — that database is where this recall came from.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: Medtronic MiniMed, Inc. — 18000 Devonshire St, Northridge, CA, 91325-1219

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Medtronic MiniMed, Inc. medical devices recalled?

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…

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00199150038978, 00199150038985; model number MMT-8600. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers listed on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Where was the recalled product sold?

It was distributed nationwide.

Related recalls