BEUDAMED
    FDA Enforcement Class II Ongoing

    Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM TIP product. Used to necrotize or coagulate soft tissue by physicians in minimally invasive surgical procedures.

    Recall: Z-0244-2023 · Reported November 23, 2022

    Enforcement

    Recall Number
    Z-0244-2023
    Event ID
    91041
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medtronic Navigation, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 23, 2022
    Initiation Date
    October 14, 2022
    Classification Date
    November 17, 2022
    Address
    826 Coal Creek Cir, N/A, Louisville, CO, 80027-9710, United States

    Description

    Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM TIP product. Used to necrotize or coagulate soft tissue by physicians in minimally invasive surgical procedures.

    Reason

    Due to a defect in the outer pouch sterile seal

    Code Info

    Product Number/CFN: 9735560 UDI-DI Code: 00763000416430 Lot Numbers: 0224382403, 0224779378, 0224824522, 0224824523, 0224824525, 0224824767, 0224824768, 0224824769

    Distribution

    U.S. Nationwide distribution including in the states AZ, CA, CO, DC, FL, IL, KY, MA, MD, ME, MI, MN, MO, NH, NJ, NY, OH, PA, RI, TX, VA, WA, and WV.

    Quantity

    95 units