Events

Recall of Device Recall EKOS Lysus Infusion System

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

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
    33408
  • Event Risk Class
    Class 2
  • Event Number
    Z-0175-06
  • Event Initiated Date
    2005-01-18
  • Event Date Posted
    2005-11-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-11-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41817
  • 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
    Potential for a faulty thermal channel offset to be reported to the software causing faulty lower temperature values to be reported which allow a power increase.
  • Action
    On 1/19/05 the firm began visiting consignees and upgrading software.

Device

Device Recall EKOS Lysus Infusion System
  • Model / Serial
    Serial numbers PT3-002, PT3-006, PT3-007, PT3-009, PT3-012, PT3-013, PT3-014
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The device was distributed to 6 hospitals/medical centers; 1 each located in AZ, OH, WA, FL, IL, and. CA. One consignee is located Germany.
  • Product Description
    Lysus¿ Infusion System - PT-3 Control . The Lysus Infusion System employs high frequency (2-2.5 MHz), low power (0.45 watt average power per transducer) ultrasound to facilitate the delivery of physician-specified fluids in the peripheral vasculature. (This system is also called the UltraFlo and EKOS Peripheral Infusion System in internal documents.) || The Lysus¿ Infusion System consists of three main components, a single use Lysus¿ Infusion Catheter System which is comprised of a Drug Delivery Catheter (DDC) and removable Ultrasound Core (USC), and a reusable EKOS PT-3 Control System. During use, fluids are delivered through the side-holes of the DDC. The USC is placed through the central lumen of the DDC to deliver ultrasound energy along the length of fluid delivery, dispersing the fluid into the intravascular treatment site. The reusable EKOS PT-3 Control Unit provides power to the system and the user interface for operator control. A reusable, non-sterile Catheter Interface Cable with Pod connects the EKOS PT-3 Control Unit to the Lysus¿ Infusion Catheter System.
  • Manufacturer
    Ekos Corp

Manufacturer

Ekos Corp
  • Manufacturer Address
    Ekos Corp, 22030 - 20th Ave SE, Ste 101, Bothell WA 98021
  • Source
    USFDA