BEUDAMED
    FDA Enforcement Class I Ongoing

    Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump

    Recall: Z-2319-2024 · Reported July 24, 2024

    Enforcement

    Recall Number
    Z-2319-2024
    Event ID
    94833
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Abiomed, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    July 24, 2024
    Initiation Date
    May 31, 2024
    Classification Date
    July 17, 2024
    Address
    24 Cherry Hill Dr, Danvers, MA, 01923-2575, United States

    Description

    Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump

    Reason

    Nine (9) Impella CP pumps failed inspection and were inadvertently released.

    Code Info

    Product No.: 1000080 (REF 0048-0003); UDI/DI: 00813502012279; Lot/Serial No.: Lot 1798046; Serial numbers: 504354, 504355, 504356, 504357, 504359, 504360, 504361, 504362, 504363.

    Distribution

    Domestic only: FL, MA, OH TX.

    Quantity

    9 units