BEUDAMED
    FDA Enforcement Class II Terminated

    Aesculap Inc.(AIC) Miethke Ventricular Catheter with Deflector/Miethke Shunt System The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.

    Recall: Z-1676-2014 · Reported June 11, 2014

    Enforcement

    Recall Number
    Z-1676-2014
    Event ID
    68091
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Aesculap, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 11, 2014
    Initiation Date
    April 21, 2014
    Classification Date
    June 2, 2014
    Termination Date
    October 20, 2014
    Address
    3773 Corporate Pkwy, Center Valley, PA, 18034-8217, United States

    Description

    Aesculap Inc.(AIC) Miethke Ventricular Catheter with Deflector/Miethke Shunt System The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.

    Reason

    AIC (USA) received information regarding 3 complaints in which the deflector did not move freely on the ventricular catheter.

    Code Info

    Catalog No: FV431T, FV434T, FV433T, FV459T, FV078P, FV494T, FV676T, FV324T Lot No: 4505150452,4505156642,4505164365,4505134636,4505150384,4505156634,4505246780,4505394315,4505150371,4505174213,4505187583,4505366616,4505134635,4505187582,4505134629,4505212089,4505199667,4505150340,4505171900,4505168804

    Distribution

    US Distribution including the states of PA, KY, NY, RI, SC, KS, TX, CT, TN and WA.

    Quantity

    48