BEUDAMED
    FDA Enforcement Class II Terminated

    Cyberonics VNS Therapy AspireHC, Model 105 Generator. The Cyberonics VNS Therapy System consists of the implantable VNS Therapy Generator, the VNS Therapy Lead, and the external programming system used to change the stimulation settings. Indicated for use as an adjunctive therapy in reducing the frequency of seizures.

    Recall: Z-0858-2015 · Reported December 31, 2014

    Enforcement

    Recall Number
    Z-0858-2015
    Event ID
    69844
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cyberonics, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    December 31, 2014
    Initiation Date
    November 20, 2014
    Classification Date
    December 23, 2014
    Termination Date
    February 8, 2016
    Address
    100 Cyberonics Blvd, Houston, TX, 77058-2069, United States

    Description

    Cyberonics VNS Therapy AspireHC, Model 105 Generator. The Cyberonics VNS Therapy System consists of the implantable VNS Therapy Generator, the VNS Therapy Lead, and the external programming system used to change the stimulation settings. Indicated for use as an adjunctive therapy in reducing the frequency of seizures.

    Reason

    The recalled product was distributed with an incorrect serial number printed on the device's label.

    Code Info

    Serial Number: 31309; UDI: (01)05425025750054(11)140917(17)160808(21)31309(99)10-0009-5705.

    Distribution

    Distributed to PA.

    Quantity

    1 unit