Events

Recall of Device Recall EKOS EkoSonic Endovascular System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by EKOS Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    71635
  • Event Risk Class
    Class 2
  • Event Number
    Z-2148-2015
  • Event Initiated Date
    2015-06-24
  • Event Date Posted
    2015-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-08-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138434
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Catheter, continuous flush - Product Code KRA
  • 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.

Device

Device Recall EKOS EkoSonic Endovascular System
  • Model / Serial
    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.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product 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.
  • Manufacturer
    EKOS Corporation

Manufacturer

EKOS Corporation
  • Manufacturer Address
    EKOS Corporation, 11911 N Creek Pkwy S, Bothell WA 98011-8809
  • Manufacturer Parent Company (2017)
    Btg Plc
  • Source
    USFDA