BEUDAMED
    FDA Recall Terminated

    VNS Therapy SENTIVA Generator Model # 1000 Labeling 26-0009-6800 Model 1000 Generator Sample Labels 26-0009-9600 Patient s Manual for Depression 26-0009-9500 Patient s Manual for Epilepsy 76-0000-5000 VNS Therapy System Physician s Manual (refer to Attachment 1)

    Recall: Z-1118-2020 · Initiated August 13, 2019

    Recall

    Recall Number
    Z-1118-2020
    Event Number
    84710
    Firm
    LivaNova USA Inc
    FEI Number
    1000117004
    Product Code
    LYJ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    August 13, 2019
    Terminated
    May 18, 2022
    Address
    100 Cyberonics Blvd, Houston, TX, 77058-2069

    Description

    VNS Therapy SENTIVA Generator Model # 1000 Labeling 26-0009-6800 Model 1000 Generator Sample Labels 26-0009-9600 Patient s Manual for Depression 26-0009-9500 Patient s Manual for Epilepsy 76-0000-5000 VNS Therapy System Physician s Manual (refer to Attachment 1)

    Reason

    Firm identified a subset of its generators that were sterilized one additional sterilization cycle, which does not meet the firm's quality specifications.

    Action

    On 08/13/2019, the firm contacted via telephone hospitals/facilities of the immediate need to remove and replace the affected devices. Reference Firm email communication dated 1/27/2020. On 08/30/2019, prescribing physicians were telephone call with a follow-up email recommending replacement of the generators during an already planned or unrelated lead replacement surgery.

    Distribution

    US: FL, GA, KS, MO, and UT. No OUS distribution

    Quantity

    6 generators