BEUDAMED
    FDA Enforcement Class II Terminated

    Cyberonics Vagus Nerve Stimulator (VNS) Therapy AspireSR Generator, Model 106

    Recall: Z-0280-2016 · Reported November 25, 2015

    Enforcement

    Recall Number
    Z-0280-2016
    Event ID
    72385
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cyberonics, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 25, 2015
    Initiation Date
    October 7, 2015
    Classification Date
    November 17, 2015
    Termination Date
    September 6, 2017
    Address
    100 Cyberonics Blvd, N/A, Houston, TX, 77058-2069, United States

    Description

    Cyberonics Vagus Nerve Stimulator (VNS) Therapy AspireSR Generator, Model 106

    Reason

    Certain Model 106 Pulse Generators demonstrate delays in sensing during use of the 'Verify Heartbeat Detection' feature and exhibit potential for decreased battery longevity.

    Code Info

    Serial Numbers: 37719, 37899, 38123, 38414, 38428, 39385, 39531, 39607, 39801, 39821, 40037, 40048, 40249, 40251, 40271, 40354, 40428, 40488, 40526, 40603, 40751, 41000, 41109, 41152, 41805, 42022, 42780

    Distribution

    US Distribution to the states of : OR, NY, GA, PA, CA, NC, KS, FL, KY, MI, TX, IL, OH, IN, UT, CO and WV.

    Quantity

    27 units