BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-2496-2025 · Reported September 10, 2025

    Enforcement

    Recall Number
    Z-2496-2025
    Event ID
    97237
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medtronic MiniMed, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 10, 2025
    Initiation Date
    June 16, 2025
    Classification Date
    September 2, 2025
    Address
    18000 Devonshire St, N/A, Northridge, CA, 91325-1219, United States

    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.

    Code Info

    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

    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