BEUDAMED
    FDA Enforcement Class II Terminated

    VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse Duo Generator Model 104; CYBERONICS, INC.

    Recall: Z-1526-2015 · Reported May 6, 2015

    Enforcement

    Recall Number
    Z-1526-2015
    Event ID
    70804
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cyberonics, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 6, 2015
    Initiation Date
    March 6, 2015
    Classification Date
    April 27, 2015
    Termination Date
    October 9, 2015
    Address
    100 Cyberonics Blvd, Houston, TX, 77058-2069, United States

    Description

    VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse Duo Generator Model 104; CYBERONICS, INC.

    Reason

    The pulse generators have a lower battery longevity than specified in their design requirement as a result of the devices being inadvertently left in a programmed ON state during manufacture.

    Code Info

    Serial Numbers: 37627, 38473, 38539, 41446, 42887, 43491, 44186, 44339, 44391, 44443, 44455, 44510, 50715

    Distribution

    AR, TX, GA, CA, MI, IN, FL, AZ, NV

    Quantity

    13 units