BEUDAMED
    FDA Enforcement Class II Ongoing

    SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst Stimulation. Used for Vagus Nerve Stimulation (VNS).

    Recall: Z-1073-2025 · Reported February 12, 2025

    Enforcement

    Recall Number
    Z-1073-2025
    Event ID
    95435
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    LivaNova USA, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 12, 2025
    Initiation Date
    December 12, 2024
    Classification Date
    January 31, 2025
    Address
    100 Cyberonics Blvd, Houston, TX, 77058-2069, United States

    Description

    SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst Stimulation. Used for Vagus Nerve Stimulation (VNS).

    Reason

    Vagus nerve stimulator generators may stop delivering stimulation due to an internal, mechanically activated component that may become stuck in a closed position, which may result in patients returning to baseline seizure frequency or depressive symptoms and in the longer term, patients may be required to undergo generator replacement surgery to replace their device.

    Code Info

    UDI-DI: 05425025750405. All Serial Numbers less than 500,000.

    Distribution

    US: AK, AZ, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, PN, SC, SD, TN, TX, VA, VT, WA, WI, WV, UT. OUS: AE, AR, AT, BE, BG, BR, CA, CL, CO, CR, CZ, DE, DK, GR, HR, IL, IN, IT, JO, KW, LB, MK, NL, OM, PA, PE, PL, QA, RO, RS, SA, SE, SG, SI, TR, TT, UK, ZA.

    Quantity

    48