BEUDAMED
    FDA Enforcement Class II Terminated

    VirtuoSaph Plus Endoscopic Vessel Harvesting System, Catalog Number: VSP550EX Product Usage: The VittuoSaph¿ Plus Endoscopic Vessel Harvesting System VSP550EX is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surge1y for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requit¿ing blunt dissection of tissue including dissection of blood vessels and dissection of blood vessels of the extremities. Extremity procedures include tissue dissection and/or vessel harvesting along the saphenous vein for coronary artery bypass grafting and peripheral artery bypass grafting or radial artery for use in coronary artery bypass grafting vc

    Recall: Z-0227-2019 · Reported October 31, 2018

    Enforcement

    Recall Number
    Z-0227-2019
    Event ID
    81094
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Terumo Cardiovascular Systems Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 31, 2018
    Initiation Date
    August 31, 2018
    Classification Date
    October 23, 2018
    Termination Date
    October 21, 2019
    Address
    125 Blue Ball Rd, N/A, Elkton, MD, 21921-5315, United States

    Description

    VirtuoSaph Plus Endoscopic Vessel Harvesting System, Catalog Number: VSP550EX Product Usage: The VittuoSaph¿ Plus Endoscopic Vessel Harvesting System VSP550EX is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surge1y for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requit¿ing blunt dissection of tissue including dissection of blood vessels and dissection of blood vessels of the extremities. Extremity procedures include tissue dissection and/or vessel harvesting along the saphenous vein for coronary artery bypass grafting and peripheral artery bypass grafting or radial artery for use in coronary artery bypass grafting vc

    Reason

    The system's IFU contains a list of generators that the have been deemed compatible. Recent reports indicate that one energy platform is not compatible with the system. Therefore, it has been removed from the list of compatible generators within the IFU.

    Code Info

    Lot Numbers: 81K

    Distribution

    Worldwide - US Nationwide in the states of FL, IL, NY, OH, TX. The products were distributed to the following foreign country: Singapore.

    Quantity

    135