BEUDAMED
    FDA Enforcement Class II Ongoing

    Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.

    Recall: Z-1030-2026 · Reported January 14, 2026

    Enforcement

    Recall Number
    Z-1030-2026
    Event ID
    98086
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Abiomed, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 14, 2026
    Initiation Date
    December 4, 2025
    Classification Date
    January 8, 2026
    Address
    22 Cherry Hill Dr, Danvers, MA, 01923-2575, United States

    Description

    Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.

    Reason

    Device packaged in incorrect outer box carton.

    Code Info

    Catalog Number: 1000482; Australian Configuration Code: 1000770; GTIN: 00813502012828; Serial No. 621454 & 621455; Exp. Date 6/30/27. *** UPDATE 05/02/2026*** Serial numbers added: 621448, 621449, 621450, and 621451;

    Distribution

    International distribution to the country of Australia and Taiwan.

    Quantity

    6 units