BEUDAMED
    FDA Recall Open, Classified

    Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.

    Recall: Z-2457-2026 · Initiated May 18, 2026

    Recall

    Recall Number
    Z-2457-2026
    Event Number
    98946
    Firm
    Abiomed, Inc.
    FEI Number
    1220648
    Product Code
    OZD
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    May 18, 2026
    Posted
    June 18, 2026
    Address
    22 Cherry Hill Dr, Danvers, MA, 01923-2575

    Description

    Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.

    Reason

    Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support.

    Action

    Johnson & Johnson MedTech/Abiomed Issued an URGETN MEDICAL DEVICE RECALL (REMOVAL) notice to its consignees on 05/18/2026 via UPS 1-day air delivery. The notice explained the reason for notification and potential patient impact Consignees were instructed to review all Impella CP Sets within inventory and quarantine affected units on hand, return all affected units using the provided return shipment label from Sedgwick, and complete and return the provided business response form. Upon receipt of returned product and completed BRF, Abiomed will provide a copy of a credit memo for the amount returned. Consignees were also instructed to forward the notification to anyone in each facility that needs to be informed and to post a copy of the notification in a visible area for awareness. If any of the subject products have been forwarded to another facility, contact that facility and provide them with this notice.

    Distribution

    US distribution to GA, IA, NE, PA, TX, WA, WI. International distribution to Czech Republic, Norway, and Japan

    Quantity

    10 units