BEUDAMED
    FDA Enforcement Class II Ongoing

    VNS Therapy Programmer, Model 3000 used with Models 103, 104, 105, 106, or 8103 VNS Therapy generators.

    Recall: Z-1563-2020 · Reported April 1, 2020

    Enforcement

    Recall Number
    Z-1563-2020
    Event ID
    84723
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    LivaNova USA Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 1, 2020
    Initiation Date
    February 4, 2020
    Classification Date
    March 24, 2020
    Address
    100 Cyberonics Blvd, N/A, Houston, TX, 77058-2069, United States

    Description

    VNS Therapy Programmer, Model 3000 used with Models 103, 104, 105, 106, or 8103 VNS Therapy generators.

    Reason

    False positive warning may occur after: 1) VNS Generator interrogated at 0mA normal output current, 2) Generator programmed to non-0mA output current, 3) In-session re-interrogation performed. Users instructed to lower output current and widen pulse width. Only system diagnostic testing evaluates output current. Users may conclude device malfunction, could lead to medical/surgical intervention.

    Code Info

    Model 3000 version 1.6

    Distribution

    U.S.: LA, ID, AZ, UT, KY, VA, TN, NY, SC, IL, IN, NC, WA, CA, OH, FL, PA, NJ, CO, TX, RI, MD, HI, OR, MA, NE, MO, OK, MS, MN, SD, VT, AR, WV, WI, MI, AL, KS, DE, NM, GA, ND, AK, MT, ME, NV, DC, MO, WY, IA, CT. Canada, and Israel.

    Quantity

    2683