BEUDAMED
    FDA Recall Terminated

    The EKOS EkoSonic Control Unit is intended exclusively for use with the EkoSonic Endovascular Device and the EkoSonic MACH4 Endovascular Device. The EkoSonic Endovascular System consists of three main components: -a single use EkoSonic Endovascular Device which is comprised of an Intelligent Drug Delivery Catheter (IDDC) and -removable MicroSonic Device (MSD), and -a reusable EKOS EkoSonic Control System. During use, fluids are delivered through the side-holes of the IDDC. The MSD is placed through the central lumen of the IDDC to deliver ultrasound energy along the length of fluid delivery, dispersing the fluid into the intravascular treatment site. The reusable EKOS EkoSonic Control Unit provides power to the system and the user interface for operator control. A reusable, nonsterile Connector Interface Cable connects the EKOS EkoSonic Control Unit to the EkoSonic Endovascular Device.

    Recall: Z-2148-2015 · Initiated June 24, 2015

    Recall

    Recall Number
    Z-2148-2015
    Event Number
    71635
    Firm
    EKOS Corporation
    FEI Number
    3001627457
    Product Code
    KRA
    Status
    Terminated
    Root Cause
    Vendor change control
    Initiated
    June 24, 2015
    Posted
    July 20, 2015
    Terminated
    August 25, 2015
    Address
    11911 N Creek Pkwy S, Bothell, WA, 98011-8809

    Description

    The EKOS EkoSonic Control Unit is intended exclusively for use with the EkoSonic Endovascular Device and the EkoSonic MACH4 Endovascular Device. The EkoSonic Endovascular System consists of three main components: -a single use EkoSonic Endovascular Device which is comprised of an Intelligent Drug Delivery Catheter (IDDC) and -removable MicroSonic Device (MSD), and -a reusable EKOS EkoSonic Control System. During use, fluids are delivered through the side-holes of the IDDC. The MSD is placed through the central lumen of the IDDC to deliver ultrasound energy along the length of fluid delivery, dispersing the fluid into the intravascular treatment site. The reusable EKOS EkoSonic Control Unit provides power to the system and the user interface for operator control. A reusable, nonsterile Connector Interface Cable connects the EKOS EkoSonic Control Unit to the EkoSonic Endovascular Device.

    Reason

    The Connector Interface Cable (CIC) was not recognized by the EkoSonic PT-3B control unit.

    Action

    Ekos sent an "Urgent Voluntary Medical Device and Replacement" letter dated June 24, 2015, to US customers. The letter identified the product the problem and the action needed to be taken by the customer. The replacement CIC and recall letter were sent by FEDERAL EXPRESS directly to the person responsible for maintaining the EkoSonic System. Tracking numbers and delivery notifications will be retained for each shipment. Letters to Risk Management and Purchasing were sent by REGISTER MAIL. The return cards will be retained for each letter. Customers with questions can contact EKOS Customer Service at 1-888-400-3567.

    Distribution

    Nationwide Distribution

    Quantity

    46 units