BEUDAMED
    FDA Enforcement Class III 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 · Reported December 24, 2014

    Enforcement

    Recall Number
    Z-0814-2015
    Event ID
    69741
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Aesculap, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 24, 2014
    Initiation Date
    November 11, 2014
    Classification Date
    December 16, 2014
    Termination Date
    June 9, 2015
    Address
    3773 Corporate Pkwy, N/A, Center Valley, PA, 18034-8217, United States

    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.

    Code Info

    Catalog No: FV660T Lot No: 4506022655

    Distribution

    Distributed in OK, and WI.

    Quantity

    4