BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1526-2015 · Initiated March 6, 2015

    Recall

    Recall Number
    Z-1526-2015
    Event Number
    70804
    Firm
    Cyberonics, Inc
    FEI Number
    1000117004
    Product Code
    LYJ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 6, 2015
    Posted
    April 27, 2015
    Terminated
    October 9, 2015
    Address
    100 Cyberonics Blvd, Houston, TX, 77058-2069

    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.

    Action

    On 03/6/2015, the recalling firm sent a recall notification letter to their consignees. The letter included an effectiveness card which is to be signed by the consignee and returned to the recalling firm.

    Distribution

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

    Quantity

    13 units