BEUDAMED
    FDA Enforcement Class I Ongoing

    Impella CP with SmartAssist intravascular micro axial blood pump, Product Numbers 0048-0024, 0048-0045, 1000080

    Recall: Z-2116-2023 · Reported July 26, 2023

    Enforcement

    Recall Number
    Z-2116-2023
    Event ID
    92321
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Abiomed, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 26, 2023
    Initiation Date
    June 14, 2023
    Classification Date
    July 14, 2023
    Address
    22 &, 24 Cherry Hill Dr, Danvers, MA, 01923-2575, United States

    Description

    Impella CP with SmartAssist intravascular micro axial blood pump, Product Numbers 0048-0024, 0048-0045, 1000080

    Reason

    There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (TAVR) resulting in destruction of the impeller blades. This has resulted in low flow from the damaged Impella system. Systemic embolization of the fractured impeller material is a possibility.

    Code Info

    UDI-DI: 00813502011371, 00813502011876, 00813502012279;

    Distribution

    Worldwide distribution - US Nationwide.

    Quantity

    9252 units