BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-0659-2016 · Reported January 27, 2016

    Enforcement

    Recall Number
    Z-0659-2016
    Event ID
    72896
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cyberonics, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 27, 2016
    Initiation Date
    December 18, 2015
    Classification Date
    January 15, 2016
    Termination Date
    March 2, 2017
    Address
    100 Cyberonics Blvd, N/A, Houston, TX, 77058-2069, United States

    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.

    Code Info

    All VNS Therapy AspireSR (Model 106) Generators; Device Identifier - (01)05425025750061

    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