BEUDAMED
    FDA Enforcement Class II Ongoing

    Fusion Bioline Vascular Graft, Part number M00201503046B0

    Recall: Z-1245-2023 · Reported March 22, 2023

    Enforcement

    Recall Number
    Z-1245-2023
    Event ID
    91671
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Maquet Cardiovascular, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 22, 2023
    Initiation Date
    January 30, 2023
    Classification Date
    March 10, 2023
    Address
    45 Barbour Pond Dr, N/A, Wayne, NJ, 07470-2094, United States

    Description

    Fusion Bioline Vascular Graft, Part number M00201503046B0

    Reason

    One (1) Fusion Bioline Vascular graft from lot 25162546, which failed guideline straightness testing, was intermingled with lot 25162549 and distributed to customers. Use of the affected graft may result in reduction of blood flow or unwanted tension causing bleeding and the formation of a pseudo-aneurysm.

    Code Info

    UDI-DI 00384409005942 Lot 25162546

    Distribution

    US Nationwide distribution in the states of FL, IN, LA, MI, MO, NC, NV, NY, PA, TN, TX, VA, WA.

    Quantity

    1 (US)