BEUDAMED
    FDA Recall Terminated

    VenaCureEVLT Perforator Vein Ablation Kit, CATALOG #: EVLT/PVAK, STERILE -- Manufactured for: AngioDynamics Inc. 603 Queensbury, NY 12804 USA, AngioDynamics UK Limited, Building 2000, Beach Drive, IQ Cambridge, Waterbeach, Cambridge, CB259TE, United Kingdom --- COMMON/USUAL NAME: Laser Surgical Instrument; CLASSIFICATION NAME: Powered Laser Surgical Instrument; DEVICE LISTING # D053485. --- Product Usage: The 810nm Diomed Laser and EVLT Procedure Kit are intended for use in the treatment of superficial vein reflux of the greater saphenous vein associated with varicosities. The Diomed D15 plus and D30 plus and EVLT Kits are indicated for treatment of incompetence and reflux of superficial veins in the lower extremity.

    Recall: Z-0739-2012 · Initiated December 6, 2011

    Recall

    Recall Number
    Z-0739-2012
    Event Number
    60591
    Firm
    Angiodynamics Worldwide Headquarters
    FEI Number
    3008319439
    Product Code
    GEX
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    December 6, 2011
    Posted
    January 13, 2012
    Terminated
    February 5, 2016
    Address
    14 Plaza Drive, Latham, NY, 12110-3421

    Description

    VenaCureEVLT Perforator Vein Ablation Kit, CATALOG #: EVLT/PVAK, STERILE -- Manufactured for: AngioDynamics Inc. 603 Queensbury, NY 12804 USA, AngioDynamics UK Limited, Building 2000, Beach Drive, IQ Cambridge, Waterbeach, Cambridge, CB259TE, United Kingdom --- COMMON/USUAL NAME: Laser Surgical Instrument; CLASSIFICATION NAME: Powered Laser Surgical Instrument; DEVICE LISTING # D053485. --- Product Usage: The 810nm Diomed Laser and EVLT Procedure Kit are intended for use in the treatment of superficial vein reflux of the greater saphenous vein associated with varicosities. The Diomed D15 plus and D30 plus and EVLT Kits are indicated for treatment of incompetence and reflux of superficial veins in the lower extremity.

    Reason

    The product was labeled with a specific indication for the treatment of perforator veins and this specific indication had not received FDA clearance prior to the product being marketed in the US.

    Action

    Angiodynamics sent an Urgent Medical Device Recall Letters and Response Forms dated December 2, 2011 to all affected consignees via Certified Mail on December 6, 2011. The recall was extended to the medical user level. The letter identified the product, problem, and actions to be taken. Customers were instructed not to use the product and to return recalled product to AngioDynamics, Inc. in Queensbury, NY. The letter states if the affected product/lot have been distributed, please inform your customers of this recall action immediately and have them return the recalled units. For questions or concerns call the Customer Service Manager at ANGIODYNAMICS Customer Service at 1-800-722-6446.

    Distribution

    (USA) Nationwide Distribution

    Quantity

    7640 units domestically