BEUDAMED
    FDA Enforcement Class II Terminated

    INTERGARD Woven Vascular Graft is a woven polyester graft coated with a bovine collagen. It has an external velour surface and non-velour inner surface. The device is available in straight tubes and bifurcated configurations, as well as hemabridge, aortic arch, thoracic aortic graft, and cardioroot configurations designed for use on the thoracic aorta

    Recall: Z-1282-2022 · Reported June 29, 2022

    Enforcement

    Recall Number
    Z-1282-2022
    Event ID
    90272
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Maquet Cardiovascular, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 29, 2022
    Initiation Date
    April 29, 2022
    Classification Date
    June 23, 2022
    Termination Date
    April 18, 2024
    Address
    45 Barbour Pond Dr, Wayne, NJ, 07470-2094, United States

    Description

    INTERGARD Woven Vascular Graft is a woven polyester graft coated with a bovine collagen. It has an external velour surface and non-velour inner surface. The device is available in straight tubes and bifurcated configurations, as well as hemabridge, aortic arch, thoracic aortic graft, and cardioroot configurations designed for use on the thoracic aorta

    Reason

    Mislabeled: Product labeled as Intergard Woven Straight graft REF IGW0032-30, D: 8 mm, L: 30 cm, contained an Intergard Woven Straight graft of D: 32 mm and L: 30 cm

    Code Info

    UDI: (01)00384401000280(11)201112(17)251031(21)1303435656GS(10)20L12; Lot number: 20L12 Serial number: 1303435656

    Distribution

    US Nationwide distribution in the state of SC.

    Quantity

    1 unit