BEUDAMED
    FDA Recall Terminated

    VNS Therapy AspireSR Generator Model 106. Indicated for use as an adjunctive therapy in reducing the frequency of seizures.

    Recall: Z-0659-2016 · Initiated December 18, 2015

    Recall

    Recall Number
    Z-0659-2016
    Event Number
    72896
    Firm
    Cyberonics, Inc
    FEI Number
    1000117004
    Product Code
    LYJ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 18, 2015
    Posted
    January 15, 2016
    Terminated
    March 2, 2017
    Address
    100 Cyberonics Blvd, Houston, TX, 77058-2069

    Description

    VNS Therapy AspireSR Generator Model 106. Indicated for use as an adjunctive therapy in reducing the frequency of seizures.

    Reason

    Recall being initiated in response to three reports of "Burst Watchdog Timeout" events occurring with the Model 106 AspireSR Generator, resulting in a device reset condition where stimulation output is disabled.

    Action

    The firm notified consignees of the issue via letter on 12/18/15. The letter identified the affected device, the issue involved, and actions to be taken. Physicians are to contact Clinical Technical Support at 866-882-8804 to report if a patient's generator has been disabled due to the issue identified. Users are to complete and return the effectiveness card as soon as possible. If further information is needed, customers can contact Clinical Technical Support at 866-882-8804 or via e-mail at [email protected].

    Distribution

    Worldwide Distribution -- United States, Austria, Belgium, Croatia, Czech Republic, Finland, France, Germany, Iceland, Italy, Netherlands, Norway, Poland, Slovakia, Spain, Sweden, Switzerland, United Kingdom, Cyprus, Israel, Kuwait, Lebanon, Oman, Qatar, Saudi Arabia, and United Arab Emirates.

    Quantity

    4,935 units