BEUDAMED
    FDA Enforcement Class II Ongoing

    Impella 5.5 Set AU; Product Code: 1000361;

    Recall: Z-2968-2024 · Reported September 11, 2024

    Enforcement

    Recall Number
    Z-2968-2024
    Event ID
    95129
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Abiomed, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 11, 2024
    Initiation Date
    August 5, 2024
    Classification Date
    September 4, 2024
    Address
    24 Cherry Hill Dr, Danvers, MA, 01923-2575, United States

    Description

    Impella 5.5 Set AU; Product Code: 1000361;

    Reason

    A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.

    Code Info

    Product Code: 1000361; UDI-DI: 00813502012927; Serial Numbers: 425570 425332 425331 463954 463955 476358 476357 481131 481130 481129 485279 485278 485280 480079 483437 466172A 491829 491830 491831 491832; Batch Numbers: 2024286281 2024286289 2024286292 2024375505 2024375511 2024398832 2024398833 2024413728 2024413879 2024413882 2024431078 2024431158 2024431171 2024431175 2024431650 2024431652 2024431653 2024431656 2024431673 2024431720;

    Distribution

    Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Brunei Darussalam, Canada, Croatia, Czeck Republic, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, Norway, Panama, Poland, Saudi Arabia, Serbia, Singapore, Slovenia, Spain, Sweden, Switzerland, Taiwan, U.A.E., United Kingdom.

    Quantity

    20 units