BEUDAMED
    FDA Enforcement Class II 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 · Reported February 19, 2020

    Enforcement

    Recall Number
    Z-1118-2020
    Event ID
    84710
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    LivaNova USA Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    February 19, 2020
    Initiation Date
    August 13, 2019
    Classification Date
    February 10, 2020
    Termination Date
    May 18, 2022
    Address
    100 Cyberonics Blvd, Houston, TX, 77058-2069, United States

    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.

    Code Info

    Model Serial No. UDI Model 1000 204460 01054250257504051119080317201205212044609910-0011-6102 Model 1000 183960 01054250257504051119080217200912211839609910-0011-6102 Model 1000 194980 01054250257504051119080217201030211949809910-0011-6102 Model 1000 204700 01054250257504051119080217201205212047009910-0011-6102 Model 1000 206720 01054250257504051119080317201219212067209910-0011-6102 Model 1000 213290 01054250257504051119080517210108212132909910-0011-6102

    Distribution

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

    Quantity

    6 generators