BEUDAMED
    FDA Recall Open, Classified

    InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users)

    Recall: Z-2496-2025 · Initiated June 16, 2025

    Recall

    Recall Number
    Z-2496-2025
    Event Number
    97237
    Firm
    Medtronic MiniMed, Inc.
    FEI Number
    3003166194
    Product Code
    NDC
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    June 16, 2025
    Posted
    September 2, 2025
    Address
    18000 Devonshire St, Northridge, CA, 91325-1219

    Description

    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.

    Action

    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

    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.

    Quantity

    6816