BEUDAMED
    FDA Enforcement Class I Ongoing

    Tandem Mobi Insulin Pump with Interoperable Technology

    Recall: Z-1520-2025 · Reported April 23, 2025

    Enforcement

    Recall Number
    Z-1520-2025
    Event ID
    96417
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Tandem Diabetes Care, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    April 23, 2025
    Initiation Date
    February 27, 2025
    Classification Date
    April 11, 2025
    Address
    12400 High Bluff Dr, San Diego, CA, 92130-3077, United States

    Description

    Tandem Mobi Insulin Pump with Interoperable Technology

    Reason

    A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps, when used with Control IQ+ technology, will cause the pump to incorrectly interpolate glucose trends when the Estimated Glucose Value (EGV) is above 255 mg/dL at the start or end of a gap in data collection due to a lapse in connection from a paired continuous glucose monitor (CGM) sensor, which can lead to under-delivery or over-delivery of insulin based on inaccurate result leading to severe cases of hypoglycemia or hyperglycemia.

    Code Info

    Software versions 7.9/UDI: 00389152480114

    Distribution

    US: AZ, CA, CO, CT, FL, HI, IA, ID, IL, IN, MD, ME, MI, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, PA, TX, UT, VA, WA, WI OUS: N/A

    Quantity

    85 units