BEUDAMED
    FDA Enforcement Class II Ongoing

    Impella CP Pump Set, Japan; Product Code: 0048-0034-JP;

    Recall: Z-2956-2024 · Reported September 11, 2024

    Enforcement

    Recall Number
    Z-2956-2024
    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 CP Pump Set, Japan; Product Code: 0048-0034-JP;

    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: 0048-0034-JP; UDI-DI: 00813502011463; Serial Numbers: 324303 323153 328083 328085; Batch Numbers: 2022079852 2022079846 2022083745 2022083747

    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

    4 units