BEUDAMED
    FDA Recall Open, Classified

    AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100

    Recall: Z-0770-2025 · Initiated November 25, 2024

    Recall

    Recall Number
    Z-0770-2025
    Event Number
    95640
    Firm
    Angiodynamics, Inc.
    FEI Number
    1319211
    Product Code
    MCW
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    November 25, 2024
    Posted
    December 27, 2024
    Address
    603 Queensbury Ave, Queensbury, NY, 12804-7619

    Description

    AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100

    Reason

    Potential for procedural delays or interruptions during use of the Auryon Atherectomy System due to the Auryon Atherectomy System not advancing to the Activation (Ready) mode.

    Action

    AngioDynamics notified consignees on about 11/25/2024 via URGENT VOLUNTARY MEDICAL DEVICE CORRECTION letter. Consignees were instructed to located affected devices on hand, place the revised Operator's Manual with affected systems, remove and destroy the Operator s Manual that is presently with the Auryon Laser System, and notify any customers of the recall if the Auryon Laser System has been redistributed to another facility. Additionally, consignees were asked to complete and return the Reply Verification Tracking Form.

    Distribution

    US Nationwide distribution to the states of AR, AZ, CA, CO, CT, FL, GA, IL, IN, KY, LA, MD, MI, MN, MO, MS, NC, NJ, NM, NY, OH, PA, RI, TN, TX, VA, WA, WI.

    Quantity

    138 units