BEUDAMED
    FDA Recall Terminated

    Cyberonics VNS Therapy AspireHC Model 105 Generator, 26-0007-4000/3. The firm name on the label is CYBERONICS, INC., Houston, TX. Vagus nerve stimulator.

    Recall: Z-0868-2020 · Initiated November 16, 2018

    Recall

    Recall Number
    Z-0868-2020
    Event Number
    84029
    Firm
    LivaNova USA Inc
    FEI Number
    1000117004
    Product Code
    LYJ
    Status
    Terminated
    Root Cause
    Manufacturing material removal
    Initiated
    November 16, 2018
    Terminated
    December 12, 2022
    Address
    100 Cyberonics Blvd, Houston, TX, 77058-2069

    Description

    Cyberonics VNS Therapy AspireHC Model 105 Generator, 26-0007-4000/3. The firm name on the label is CYBERONICS, INC., Houston, TX. Vagus nerve stimulator.

    Reason

    This recall is an expansion of Z-3019-2017 and Z-3020-2017, which was initiated to fix the devices premature battery depletion, caused by electrical leakage on the circuit board assemblies of the Models 105 and 106 generators. *Note this recall occurred in November 2018.

    Action

    The recalling firm issued Dear Doctor letters dated 11/16/2018 explaining the reason for the voluntary correction and pointing out a correction was previously initiated in June, 2017, related to this issue for devices distributed prior to October, 2015.

    Distribution

    Distribution US nationwide, including Puerto Rico. There was no foreign/military/government consignees.

    Quantity

    106 devices