BEUDAMED
    FDA Enforcement Class I 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 · Reported November 23, 2022

    Enforcement

    Recall Number
    Z-0154-2023
    Event ID
    90987
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Insulet Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    November 23, 2022
    Initiation Date
    October 17, 2022
    Classification Date
    November 15, 2022
    Termination Date
    September 17, 2024
    Address
    100 Nagog Park, N/A, Acton, MA, 01720-3440, United States

    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.

    Code Info

    Part Number/UDI-DI 18239 : 10385082000009 PT 000030: 10385082000122 PT 000010: 10385082000139 PT 000011: 10385082000146 All Serial Numbers and Lots

    Distribution

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

    Quantity

    248,288 US; 167,802 OUS