BEUDAMED
    FDA Enforcement Class II Ongoing

    InPen App, Model/CFN Number: MMT-8061 (Android Users)

    Recall: Z-0958-2026 · Reported December 24, 2025

    Enforcement

    Recall Number
    Z-0958-2026
    Event ID
    97904
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medtronic MiniMed, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 24, 2025
    Initiation Date
    November 13, 2025
    Classification Date
    December 18, 2025
    Address
    18000 Devonshire St, Northridge, CA, 91325-1219, United States

    Description

    InPen App, Model/CFN Number: MMT-8061 (Android Users)

    Reason

    When app is uninstalled and reinstalled, insulin pen software issue causes Choose Notification Style Screen to not show during setup so users can't choose to allow notifications to override phone settings when on mute/Do Not Disturb, and previously set up override permission is deleted, so audible and vibratory notifications not received, which may lead to delayed insulin therapy, hyperglycemia.

    Code Info

    Software Versions: 7.5.0, 7.5.1, and 8.0.0. UDI-DI: 00763000974596

    Distribution

    US: IL, AZ, MN, NE, KS, TN, CA, FL, TX, WA, MO, NC, NY, WI, IN, ME, CT, RI, MD, PA, OK, KY, MA, DE, UT, ID, VA, MI, OH, LA, NJ, IA, MT, HI, AR, OR, SC, AL, CO, WY, VT, NV, GA, MS, SD, AK, WV, NH, ND, NM. OUS: Austria, Belgium, Chile, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Luxembourg, Netherlands, Norway, Poland, Portugal, Romania, South Africa, Spain, Sweden, Switzerland, United Kingdom

    Quantity

    8251