BEUDAMED
    FDA Recall Open, Classified

    Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434. Introducer Product Code: 1000434.

    Recall: Z-2599-2026 · Initiated May 22, 2026

    Recall

    Recall Number
    Z-2599-2026
    Event Number
    99002
    Firm
    Abiomed, Inc.
    FEI Number
    1220648
    Product Code
    DYB
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    May 22, 2026
    Posted
    June 25, 2026
    Address
    22 Cherry Hill Dr, Danvers, MA, 01923-2575

    Description

    Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434. Introducer Product Code: 1000434.

    Reason

    Potential for thrombus formation during prolonged use of the introducer.

    Action

    Abiomed notified consignees on about 05/22/2026, via letter titled "URGENT MEDICAL DEVICE RECALL (REMOVAL)." Consignees were made aware of the issue and that if thrombus formation were to occur, the user may encounter difficulty aspirating the sheath sidearm or valve and may observe thrombus in the syringe or sidearm post aspiration or around the valve post CP pump removal. They were instructed to review inventory for affected units and quarantine them, arrange for their return using the provided shipment label from Sedgwick, and complete and return the provided business response form. Consignees were also instructed to forward the notification to anyone in the facility that needs to be informed, if any of the subject products have been forwarded to another facility, contact that facility and provide them with the notification, and to post a copy of the notification in a visible area for awareness.

    Distribution

    Worldwide - US Nationwide distribution in the states of FL, IL, MN, NJ, NY, VA and the country of Japan.

    Quantity

    3 units