BEUDAMED
    FDA Enforcement Class II Ongoing

    TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005

    Recall: Z-0127-2024 · Reported November 1, 2023

    Enforcement

    Recall Number
    Z-0127-2024
    Event ID
    93087
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Acclarent, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 1, 2023
    Initiation Date
    September 21, 2023
    Classification Date
    October 20, 2023
    Address
    31 Technology Dr Suite 200, N/A, Irvine, CA, 92618-2346, United States

    Description

    TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005

    Reason

    When using affected curette and software, there is a discrepancy between the actual curette tip location and the location displayed on navigation systems intended for use during surgical procedures of the Ear Nose and Throat (ENT) and ENT skull base surgery, which may cause delayed/prolonged surgery, cerebrospinal fluid leak, visual impairment, or skull base structural damage.

    Code Info

    TruDi Navigation System, UDI-DI: 10846835018639, software version: V2.3.1 Update (2.3.1.144 and 2.3.1.166)

    Distribution

    US: CA, IL, WI, MA, TX, CO, FL, ID, KS, OH, OR, NE, MO, AZ, HI, TN, NY, ME, SC, NC, CT, DC, MN, LA, OK, PA, AL, IA, MI, SD

    Quantity

    141