Events

Recall of Device Recall EKOS EkoSonic Endovascular Device

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
    73195
  • Event Risk Class
    Class 2
  • Event Number
    Z-0864-2016
  • Event Initiated Date
    2016-01-21
  • Event Date Posted
    2016-02-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-03-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143565
  • 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 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.
  • Action
    All affected consignees were contacted by telephone January 20- 22, 2016. The URGENT  VOLUNTARY PRODUCT RECALL letter, dated January 21, 2016, was sent to consignees. Consignees were advised that replacement devices were shipped to their facility on January 21, 2016 and should arrive there on January 22, 2016. Consignees with questions can call: Jocelyn Kersten Vice President, Regulatory and Clinical Affairs EKOS Corporation, a BTG International Group Company 425-415-3132 Jocelyn.kersten@ekoscorp.com

Device

Device Recall EKOS EkoSonic Endovascular Device
  • Model / Serial
    Lot Number 150910004. Expiration date is August 15, 2018.  Serial numbers: 001, 002, 003, 004, 005, 006, 007, 008, 009, 010
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in the states of AZ, CA, MA, MI, OH, and VA.
  • Product 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.
  • 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