BEUDAMED
    FDA Recall Terminated

    Aesculap Miethke Shunt System, miniNAV Valve: The Miethke Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.

    Recall: Z-0814-2015 · Initiated November 11, 2014

    Recall

    Recall Number
    Z-0814-2015
    Event Number
    69741
    Firm
    Aesculap, Inc.
    FEI Number
    2916714
    Product Code
    JXG
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    November 11, 2014
    Posted
    December 16, 2014
    Terminated
    June 9, 2015
    Address
    3773 Corporate Pkwy, Center Valley, PA, 18034-8217

    Description

    Aesculap Miethke Shunt System, miniNAV Valve: The Miethke Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.

    Reason

    Aesculap Inc. (AIC (USA)) initiated a recall of Miethke Shunt System accessories due to missing patients' labels for the miniNAV (FV660T). There are no patient injuries resulting from this issue.

    Action

    An important correction & removal notification, dated November 11, 2014, was sent to consignees that identified the product, problem, and action to be taken. Consignees were asked to complete the distribution inventory sheet and return it. Aesculap sales representatives would be coordinating pick up of affected devices.

    Distribution

    Distributed in OK, and WI.

    Quantity

    4