BEUDAMED
    FDA Enforcement Class II Terminated

    VASOVIEW HEMOPRO VH-3500 ENDOSCOPIC VESSEL HARVESTING SYSTEM Product Usage: The VASOVIEW HEMOPRO VH-3500 is designed for use in conjunction with the 7-mm Endoscope and is intended for specific use with the VASOVIEW HEMOPRO Power Supply.

    Recall: Z-1456-2017 · Reported March 22, 2017

    Enforcement

    Recall Number
    Z-1456-2017
    Event ID
    76326
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Maquet Cardiovascular, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 22, 2017
    Initiation Date
    January 27, 2017
    Classification Date
    March 13, 2017
    Termination Date
    April 12, 2018
    Address
    45 Barbour Pond Dr, N/A, Wayne, NJ, 07470-2094, United States

    Description

    VASOVIEW HEMOPRO VH-3500 ENDOSCOPIC VESSEL HARVESTING SYSTEM Product Usage: The VASOVIEW HEMOPRO VH-3500 is designed for use in conjunction with the 7-mm Endoscope and is intended for specific use with the VASOVIEW HEMOPRO Power Supply.

    Reason

    Maquet has received several complaints involving the VASOVIEW HEMOPRO VH-3500 which involve the device exhibiting the failure mode of intermittent or no power.

    Code Info

    25126012, 25126080, 25126250, 25126375, 25126542, 25126659, 25128301, 25128602, 25128820, 25128905, 25129016, 25129155, 25129199, 25129239, 25129286, 25129335, 25129416, 25129513

    Distribution

    US Nationwide Distribution

    Quantity

    4283 units