BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1030-2026 · Initiated December 4, 2025

    Recall

    Recall Number
    Z-1030-2026
    Event Number
    98086
    Firm
    Abiomed, Inc.
    FEI Number
    1220648
    Product Code
    OZD
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    December 4, 2025
    Posted
    January 8, 2026
    Address
    22 Cherry Hill Dr, Danvers, MA, 01923-2575

    Description

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

    Reason

    Device packaged in incorrect outer box carton.

    Action

    The consignee was sent a RECALL notice dated 12/4/25. The consignee is instructed to identify the two affected pumps in their inventory, quarantine them, and return the units to Abiomed, Danvers. The consignee is to complete and return the provided business reply form to their local Abiomed representative.

    Distribution

    International distribution to the country of Australia.

    Quantity

    2 units