InPen App (Medtronic) – Insulin Dosing Error (2025)
Software errors can potentially miss insulin dose reminders for diabetes management.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users)
Brand
Medtronic MiniMed, Inc.
Lot Codes / Batch Numbers
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
Products Sold
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
Medtronic MiniMed, Inc. is recalling InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users) due to 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 insuli. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On 6/16/2025, correction notices were emailed to customers who were asked to do the following: Actions Required: Users of InPen app software should update to version 7.5.1 or higher. For iOS Users - Verify your app version: - On the home screen, navigate to the Settings menu (lower right corner). - Select Help and Support. - Note the App Version displayed. - Open the App Store. - Tap your profile icon at the top of the screen. - Scroll to see pending updates. - Tap Update next to the InPen app icon. For Android Users - Verify your app version: - On the home screen, navigate to the Settings menu (lower right corner). - Select Help and Support. - Note the App Version displayed. - Open the Google Play Store. - Tap your profile icon at the top of the screen, then select Manage apps & device. - Tap Updates available or search for the InPen app. - Tap Update next to the InPen app icon. Firm's 24-Hr Technical Support: 1-800-646-4633
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
GA
Page updated: Jan 10, 2026