BEUDAMED
    FDA Enforcement Class II Ongoing

    Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures through a sternotomy incision approach. Product Code: OM-10000Z

    Recall: Z-0137-2024 · Reported November 1, 2023

    Enforcement

    Recall Number
    Z-0137-2024
    Event ID
    93085
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Maquet Cardiovascular, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 1, 2023
    Initiation Date
    September 13, 2023
    Classification Date
    October 22, 2023
    Address
    45 Barbour Pond Dr, N/A, Wayne, NJ, 07470-2094, United States

    Description

    Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures through a sternotomy incision approach. Product Code: OM-10000Z

    Reason

    Housing Mount Jaw of these devices breaking during normal use and may result in injury to the epicardial tissue or vasculature, or a coronary artery or previously placed bypass graft, or could result in procedural delay and/or conversion.

    Code Info

    UDI-DI: 00607567100008 Lot Numbers: 3000188485, 3000193165, 3000193670, 3000195673, 3000198652, 3000199944, 3000201253, 3000204442

    Distribution

    Nationwide Foreign: AT BE DE ES FR GB IT JP KR LU NL PL PT TR

    Quantity

    2951 units