Reported Sep 10, 2025 · Ongoing
InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users)
Medtronic MiniMed, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic MiniMed, Inc. · 18000 Devonshire St · Northridge, CA · 91325-1219
Is this the product you have?
- InPen App
- CFNMMT-8060 (iOS Users) and MMT-8061 (Android Users)
- Lot codes and dates
- UDI-DI0763000B000122075
- CFN/Software Version
MMT-8060/7.0.07.1.07.2.0 and 7.5.0 MMT-8061/7.0.07.0.17.1.07.1.17.2.0 and 7.5.0
- Amount recalled
- 6816
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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