BEUDAMED
    FDA Enforcement Class II Terminated

    HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-1 Branch, Product Code: M00202175832P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.

    Recall: Z-1874-2020 · Reported May 13, 2020

    Enforcement

    Recall Number
    Z-1874-2020
    Event ID
    85420
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Maquet Cardiovascular, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 13, 2020
    Initiation Date
    April 7, 2020
    Classification Date
    May 4, 2020
    Termination Date
    November 5, 2021
    Address
    45 Barbour Pond Dr, N/A, Wayne, NJ, 07470-2094, United States

    Description

    HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-1 Branch, Product Code: M00202175832P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.

    Reason

    Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts

    Code Info

    Serial Numbers: 1071592227 1076652332 1076651924 1077530262 1077532425 1077534451 1115874139 1117809371 1117812408 1117796327 1117794535 1117789960 1117809020 1117815935 1117814805 1123951175 1123988085 1124019782 1124040327 1124021181 1124006732 1129589959 1129634943 1129655139 1136595906 1137613764 1139537978 1143684135 1146721032 1146770074 1146753833 1146714548 1146754846 1146767428 1160528085 1160522358 1160540588 1160489919 1185176976 1185742445 1187300337 1187355243 1187336585 1072226283 1115901732 1117786179 1124002055 1123995779 1137600948 1139535952 1143697322 1146723800 1146725221 1160566357

    Distribution

    Worldwide distribution - US Nationwide distribution and the countries of Dubai, Argentina, Austria, Belgium, Brazil, Japan, Canada, China, Germany, Spain, Finland, France, UK, Hongkong, Italy, Korea, Netherlands, Poland, Serbia, Sweden.

    Quantity

    N/A