BEUDAMED
    FDA Recall Terminated

    Visualase Cooled Laser Applicator System (VCLAS). The VCLAS system consists of the Visualase Laser Diffusing Fiber (LDF) and the Visualase Cooled Catheter System (CCS). The LDF and disposables (including the CCS) is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels of the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, pulmonology, radiology and urology.

    Recall: Z-1672-2016 · Initiated May 9, 2016

    Recall

    Recall Number
    Z-1672-2016
    Event Number
    74096
    Firm
    Medtronic Navigation, Inc.
    FEI Number
    1000517638
    Product Code
    GEX
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    May 9, 2016
    Posted
    May 16, 2016
    Terminated
    December 19, 2016
    Address
    826 Coal Creek Cir, Louisville, CO, 80027-9710

    Description

    Visualase Cooled Laser Applicator System (VCLAS). The VCLAS system consists of the Visualase Laser Diffusing Fiber (LDF) and the Visualase Cooled Catheter System (CCS). The LDF and disposables (including the CCS) is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels of the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, pulmonology, radiology and urology.

    Reason

    Potential for the Visualase Cooled Laser Applicator System (VCLAS) catheters to melt during procedures.

    Action

    Medtronic will be sending a Medical Device Safety Notification letter FedEx on May 18, 2016. Each customer will be asked to complete and return a response form to Medtronic. This is a safety alert notification and does not require return of devices. We are committed to patient safety and appreciate your prompt attention to this matter. If you have any questions regarding this action, please contact Medtronic Technical Services at 1-800-595-9709.

    Distribution

    Distributed within the US, Netherlands, Canada and Australia and to govt/VA/military consignees.

    Quantity

    120