BEUDAMED
    FDA Enforcement Class II Terminated

    EkoSonic Endovascular System, Catalog Number 500-56112. It 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, non-sterile Connector Interface Cable connects the EKOS EkoSonic Control Unit to the EkoSonic Endovascular Device.

    Recall: Z-0864-2016 · Reported March 2, 2016

    Enforcement

    Recall Number
    Z-0864-2016
    Event ID
    73195
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    EKOS Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 2, 2016
    Initiation Date
    January 21, 2016
    Classification Date
    February 24, 2016
    Termination Date
    March 15, 2016
    Address
    11911 N Creek Pkwy S, N/A, Bothell, WA, 98011-8809, United States

    Description

    EkoSonic Endovascular System, Catalog Number 500-56112. It 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, non-sterile Connector Interface Cable connects the EKOS EkoSonic Control Unit to the EkoSonic Endovascular Device.

    Reason

    The EkoSonic kit, including the individually labeled MicroSonic Device (MSD) and Intelligent Drug Delivery Catheter (IDDC) are labeled with a 135 cm working length, and programmed with a 135 cm family code, however the MSD actual working length is 106 cm.

    Code Info

    Lot Number 150910004. Expiration date is August 15, 2018. Serial numbers: 001, 002, 003, 004, 005, 006, 007, 008, 009, 010

    Distribution

    Distributed in the states of AZ, CA, MA, MI, OH, and VA.

    Quantity

    10 units