BEUDAMED
    FDA Enforcement Class II Terminated

    Aesculap(R) - Miethke Shunt System, FT040T - Control Reservoir Set w/Distal Catheter and FT075P 0 Ventric Cathet, w/Stylet and RT-ANG Guide Central Nervous System Shunt and Components intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.

    Recall: Z-0805-2013 · Reported February 20, 2013

    Enforcement

    Recall Number
    Z-0805-2013
    Event ID
    63244
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Aesculap, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 20, 2013
    Initiation Date
    June 4, 2012
    Classification Date
    February 12, 2013
    Termination Date
    January 8, 2014
    Address
    3773 Corporate Pkwy, Center Valley, PA, 18034-8217, United States

    Description

    Aesculap(R) - Miethke Shunt System, FT040T - Control Reservoir Set w/Distal Catheter and FT075P 0 Ventric Cathet, w/Stylet and RT-ANG Guide Central Nervous System Shunt and Components intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.

    Reason

    The deflector may not move freely on the ventricular catheter. The deflector comes pre-positioned at the 5 cm mark on the catheter. In some cases the surgeon will want to adjust the deflector to a different location on the catheter before placing it in the ventricle. There is a small percentage of cases where aggressively attempting to adjust the deflector has a potential to cause the catheter

    Code Info

    Lots 4503489878, 4503792749, 4503682927, 4503508385, 4503789879, 4503800248 and 4503682935.

    Distribution

    Nationwide Distribution including MI, PA and TX.

    Quantity

    11