Insulin App Recall: Medtronic MiniMed InPen
Announced 2026-08-26 · FDA
Medtronic MiniMed recalls InPen App for iOS and Android 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. The issue does not affect insulin delivery, long-acting dose reminders, or CGM alerts; users can still use the pen to calculate a dose, deliver insulin, record the dose date/time, and view CGM data. The issue was identified during internal testing before release in the US; no MDRs or complaints have been reported, and 6,816 units were distributed internationally.
| Brand | Medtronic MiniMed, Inc. |
|---|---|
| Product | InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users) |
| Reason | 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. |
| Severity | moderate |
| Units affected | 257 |
| Distribution | International distribution to the countries of Argentina, Australia, Austria, Belgium, Bermuda, Chile, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Luxembourg, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom. |
| Agency | FDA |
| Recall / campaign no. | 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 |
WHAT YOU SHOULD DO
- Update the InPen App to the latest version and install any available patches.
- Do not rely solely on the app's reminders; continue to monitor your blood glucose and use the pen to dose as directed.
- If you notice missed reminders or incorrect glucose value corrections, contact Medtronic support and your healthcare provider for guidance.
- Watch for official recall notices and software-update communications from FDA and Medtronic and install updates promptly.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.