BEUDAMED
    FDA Enforcement Class II 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 · Reported July 29, 2015

    Enforcement

    Recall Number
    Z-2148-2015
    Event ID
    71635
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    EKOS Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 29, 2015
    Initiation Date
    June 24, 2015
    Classification Date
    July 20, 2015
    Termination Date
    August 25, 2015
    Address
    11911 N Creek Pkwy S, N/A, Bothell, WA, 98011-8809, United States

    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.

    Code Info

    CIC Serial Numbers: 19598-095, 19598-097, 19598-099, 19598-100, 19598-102, 19598-103, 19598-106, 19598-107, 19598-108, 19598-110, 19598-111, 19598-112, 19598-113, 19598-114, 19598-115, 19598-116, 19598-117, 19598-118, 19598-119, 19598-120, 19598-122, 19598-125, 19598-126, 19598-127, 19598-128, 19598-130, 19598-131, 19598-132, 19598-133, 19598-135, 19598-136, 19598-139, 19598-140, 19598-141, 19598-143, 19598-144, 19598-145, 19598-146, 19598-147, 19598-151, 19598-152, 19598-153, 19598-154, 19598-156, 19598-157, 19598-158.

    Distribution

    Nationwide Distribution

    Quantity

    46 units