BEUDAMED
    FDA Recall Terminated

    18239: ASM Omnipod Dash PDM, insulin delivery system. PT-000010: Assembly, Dash Final PDM U100, mg/dL PT-000011: Assembly, Dash Final PDM U100, mmol/L PT-000030: Assembly, DASH PDM, Canada Remote Controller (Personal Diabetes Manager or PDM) associated with Insulin Pump (Pod) *The part numbers above may be incorporated into higher level assemblies such as DASH Starter Kits.

    Recall: Z-0154-2023 · Initiated October 17, 2022

    Recall

    Recall Number
    Z-0154-2023
    Event Number
    90987
    FEI Number
    3014585508
    Product Code
    LZG
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 17, 2022
    Posted
    November 15, 2022
    Terminated
    September 17, 2024
    Address
    Insulet Corporation 100 Nagog Park, Acton, MA, 01720-3440

    Description

    18239: ASM Omnipod Dash PDM, insulin delivery system. PT-000010: Assembly, Dash Final PDM U100, mg/dL PT-000011: Assembly, Dash Final PDM U100, mmol/L PT-000030: Assembly, DASH PDM, Canada Remote Controller (Personal Diabetes Manager or PDM) associated with Insulin Pump (Pod) *The part numbers above may be incorporated into higher level assemblies such as DASH Starter Kits.

    Reason

    The firm has become aware of PDM battery issues, including battery swelling, fluid leaking from the battery, and extreme overheating, which may pose a fire hazard. The firm has received a complaint alleging fire as a result of thermal energy from a DASH PDM.

    Action

    On October 17, 2022, the firm notified customers via Urgent Medical Device Correction letters sent via email. The firm followed up with physical mailers. Customers will receive updated Omnipod DASH PDMs in the coming months. Customers do not need to call to receive an updated device, one will automatically be shipped to you when available. Customers were provided with additional precautions to follow until they receive replacement units. If you have any questions regarding the information provided in this Medical Device Correction, please visit our website at www.omnipod.com/insulet-alerts or call 1-800-641-2049 to speak with a dedicated staff member of the Insulet Customer Care team who will be available 24 hours a day, 7 days a week.

    Distribution

    Worldwide Distribution: US nationwide, Canada, Europe, Australia, and the Middle East.

    Quantity

    248,288 US; 167,802 OUS