BEUDAMED
    FDA Recall Terminated

    VNS Therapy Aspire HC Generator and VNS, Model 105 Cyberonics, Inc. 100 Cyberonics Blvd., Houston, TX 77058 For implantation in humans to treat Epilepsy and Depression.

    Recall: Z-0210-2012 · Initiated August 12, 2011

    Recall

    Recall Number
    Z-0210-2012
    Event Number
    59818
    Firm
    Cyberonics, Inc
    FEI Number
    1000117004
    Product Code
    LYJ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    August 12, 2011
    Posted
    November 18, 2011
    Terminated
    August 20, 2012
    Address
    100 Cyberonics Blvd, Houston, TX, 77058-2069

    Description

    VNS Therapy Aspire HC Generator and VNS, Model 105 Cyberonics, Inc. 100 Cyberonics Blvd., Houston, TX 77058 For implantation in humans to treat Epilepsy and Depression.

    Reason

    The devices are being recalled because the output current delivered to the vagus nerve is less than the design intent and there is a potential charge imbalance at the lead cathode and generator-can during stimulation.

    Action

    Cyberonics sent a Field Safety Alert on August 15, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The firm decided to recall and initiated contact with implanting facilities in the United States on 08/15/2011. A Field Safety Alert was delivered on 09/19/2011 to implanting facilities. Customers were instructed not to prescribe AspireHC pulse generators for implant until Cyberonics resumes shipment of AspireHC pulse generators that have the issue remedied. Cyberonics recommends that physicians continue their current practice of titrating programming parameters for patients implanted with an AspireHC pulse generator to achieve appropriate clinical outcomes, paying particular attention to report of: Lack or loss of efficacy Pain, inflammation, swelling/edema in the neck area; and/or Patient perception of stimulation or muscle twitching in the area surrounding the implant. Cyberonics recommended routine systems diagnostic testing to aid in device and patient monitoring. Physicians may contact Clinical Technical Support at 866-882-8804 or via email at [email protected]. For questions regarding this recall call 281-228-7323.

    Distribution

    Worldwide Distribution - USA including TN, TX, IL, OH, FL, CA, CO, OR, AZ, NY, PA, MO, NJ, WI, OK, MI, ID, KY, IA, MA, NE, GA, LA, NY, and Norway.

    Quantity

    340 units