BEUDAMED
    FDA Recall 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 · Initiated June 4, 2012

    Recall

    Recall Number
    Z-0805-2013
    Event Number
    63244
    Firm
    Aesculap, Inc.
    FEI Number
    2916714
    Product Code
    JXG
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 4, 2012
    Posted
    February 12, 2013
    Terminated
    January 8, 2014
    Address
    3773 Corporate Pkwy, Center Valley, PA, 18034-8217

    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

    Action

    Aesculap sent an Important Recall Notification letter dated June 4, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return the contact their local sales representative or customer service department at 1-800-282-9000 to return the affected product. Customers were also instructed to complete the Inventory Sheet attached to the letter with the quantity being returned. If customers could not locate the affected product they should provide an explanation as to why the inventory will not be returned. Customers with questions should call 610-984-9251 or 610-984-9291. For questions regarding this recall call 1-800-234-9179, ext 5067.

    Distribution

    Nationwide Distribution including MI, PA and TX.

    Quantity

    11