BEUDAMED
    FDA Enforcement Class I Ongoing

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

    Recall: Z-2457-2026 · Reported June 24, 2026

    Enforcement

    Recall Number
    Z-2457-2026
    Event ID
    98946
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Abiomed, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 24, 2026
    Initiation Date
    May 18, 2026
    Classification Date
    June 18, 2026
    Address
    22 Cherry Hill Dr, Danvers, MA, 01923-2575, United States

    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.

    Code Info

    GTIN: 00813502012279. Product Codes (Serial Number): 1000080 (677223, 672986, 673252, 644591, 645428, 644314, 613525), 1000851 (636173), 0048-0014 (499250), 0048-0024-JP (661216).

    Distribution

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

    Quantity

    10 units