Events

Recall of Device Recall EkoSonic MACH4 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
    62020
  • Event Risk Class
    Class 2
  • Event Number
    Z-2023-2012
  • Event Initiated Date
    2012-05-24
  • Event Date Posted
    2012-07-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-11-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109705
  • 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
    Ekos corporation have recently received several complaints from users where the radio-opaque marker bands on the intelligent drug delivery catheter (iddc) were dislodged during a procedure and report of microsonic device (msd) breaking during insertion or operation.
  • Action
    Starting May 25, 2012 to May 31, 2012, EKOS Corporation sent "New warnings in EkoSonic Endovascular Device Instruction for Use" letter, dated May 24, 2012, to all affected customers. Attached with the notification letter is the revised EKOS MACH4 Endovascular Device Instructions for Use in Peripheral Vasculature. Customers are informed of the complaints about the radio-opaque marker bands on the Intelligent Drug Delivery Catheter (IDDC) were dislodged during a procedure and reports of the MicroSonic Device (MSD) breaking during insertion or operation. Customers with questions about the revised Instruction for Use, please contact EKOS Corporation at 425-415-3132.

Device

Device Recall EkoSonic MACH4 Endovascular Device
  • Model / Serial
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including OH, KY, and TN and the countries of Switzerland, Germany, Austria, Czech Republic, Slovakia Republic, Poland, Netherlands, Belgium, Luxembourg, United Kingdom, Republic of Ireland, Slovenia, Costa Rica, Argentina, Brazil, Dominican Republic, Taiwan, Korea, Greece, Mexico, Italy, Uruguay, Paraquay, Yugoslavia, New Zealand, India, Venezuela, South America, Norway, Sweden, Denmark, Turkey, Great Britain, Israel, Spain, Portugal, Greece, Korea, China, and Japan.
  • Product Description
    EkoSonic MACH4 Endovascular Device (Catalog #500-55106, 500-55112; 500-55118; 500-55124; 500-55130; 500-55140; 500-55150; 500-54106; 500-56130; 500-56140; 500-56150) is a catheter, continuous infusion. it consists of the Intelligent Drug Delivery Catheter (IDDC) and the MicroSonic Device (MSD). || It is intended for the controlled and selective infusion of physician-specific fluids, including thrombolytics, into the peripheral vasculature. || All therapeutic agents utilized with the EkoSonic Endovascular System should be fully prepared and used according to the instruction for use of the specific therapeutic agent. || The Kit MACH4 is labeled in parts: "***EkoSonic MACH4 Endovascular Device***MicroSonic Device and Intelligent Drug Delivery Catheter***". || The Pouch MSD is labeled in parts: "***EKOS***MicroSonic Device***Sterile***". || EkoSonic Endovascular System is a catheter, continuous infusion. It is intended for the controlled and selective infusion of physician-specific fluids, including thrombolytics, into the peripheral vasculature. The system is also intended for the infusion of solutions into pulmonary arteries.
  • 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