Use caution Medical device recall · FDA · Published June 16, 2025

Medtronic MiniMed InPen App Software Recall: Missed Insulin Reminders Risk Hyperglycemia

Medtronic MiniMed recalls InPen App for iOS and Android users with software versions 7.0.0-7.5.0 due to missed insulin dose reminders. This could lead to hyperglycemia if users don't receive alerts for high glucose levels. The device itself still works for insulin delivery and CGM data.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2496-2025Medical device Medtronic MiniMed ›

Use caution until it’s fixed

Medtronic MiniMed, Inc. is recalling InPen App for iOS and Android users due to software design errors that could lead to a missed short-acting insulin dose reminder and a recommendation to correct a high glucose value. It does not impact insulin delivery, long-acting insulin dose reminders, or CGM alerts, and users can still use the pen itself to calculate a dose, deliver insulin, record the dose date/time, and view CGM data. This issue was identified during internal testing before release in the US but after release to OUS customers, no complaints or MDRs related to this recall have been reported. Use of the affected device may result hyperglycemia by failing to alert the user and delay treatment of diabetes.

Take action

Contact the company

Recalling firmMedtronic MiniMed, Inc.18000 Devonshire St · Northridge, CA 91325-1219

✎ GovInfoNow plain-language explainer

Medtronic MiniMed is recalling its InPen App for iOS and Android users with specific software versions because software errors might cause missed insulin dose reminders. This could lead to high blood sugar levels if users don't get alerts for high glucose values, but the device still functions for insulin delivery and glucose monitoring. Read more at govinfonow.com/recall/52036-medtronic-minimed-inpen-app-software-recall-missed-insulin-reminders-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/52036-medtronic-minimed-inpen-app-software-recall-missed-insulin-reminders-risk · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2496-2025

Cite this page

“Medtronic MiniMed InPen App Software Recall: Missed Insulin Reminders Risk Hyperglycemia.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/52036-medtronic-minimed-inpen-app-software-recall-missed-insulin-reminders-risk. Based on FDA recall #Z-2496-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2496-2025%22&limit=1).

The FDA announced on June 16, 2025, that Medtronic MiniMed is recalling the InPen App for iOS and Android users due to software errors that may cause missed insulin dose reminders. The agency stated the issue does not impact actual insulin delivery but could result in hyperglycemia by delaying treatment.

How to tell if you have it

Brand: Medtronic MiniMed
Product: InPen App
CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users)
UDI-DI: 0763000B000122075
CFN/Software Version: MMT-8060/7.0.0, 7.1.0, 7.2.0 and 7.5.0; MMT-8061/7.0.0, 7.0.1, 7.1.0, 7.1.1, 7.2.0 and 7.5.0
Units affected: 6816

The hazard

GovInfoNow's records show the software design errors could lead to a missed short-acting insulin dose reminder and a recommendation to correct a high glucose value. Use of the affected device may result in hyperglycemia by failing to alert the user and delay treatment of diabetes. No complaints or MDRs related to this recall have been reported.

Context

GovInfoNow's records show Medtronic MiniMed, Inc. has 13 other recalls on record since November 15, 2023. Other recent recalls of similar products include Medtronic MiniMed Go App Version 1.0.0/1.1.0 May Cause Missed Insulin Doses (June 16, 2026) and Dexcom G7 CGM App: Risk of Missing Glucose Alerts Due to Software Defect (April 14, 2026).

How to tell if you have this one

Check your InPen App version: iOS users with MMT-8060 software versions 7.0.0, 7.1.0, 7.2.0, or 7.5.0; Android users with MMT-8061 software versions 7.0.0, 7.0.1, 7.1.0, 7.1.1, 7.2.0, or 7.5.0. The recall was issued for devices sold in the US after internal testing.

Brand
Medtronic MiniMed
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check App Version
Review your InPen App version to see if it matches the affected software versions listed in the recall.
Update Software
Update to a newer version of the app to fix the software errors that could cause missed reminders.

How this recall unfolded

Recall timeline

FDA published this recall 3 months after the firm started it.

Jun 16, 2025Firm started the recall
Sep 2, 2025FDA classified it Class II
Sep 10, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/52036-medtronic-minimed-inpen-app-software-recall-missed-insulin-reminders-risk">Medtronic MiniMed InPen App Software Recall: Missed Insulin Reminders Risk Hyperglycemia (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2496-2025 (June 16, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2496-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.