Events

Recall of Device Recall LuMend OUTBACK LTD

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cordis 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
    49392
  • Event Risk Class
    Class 2
  • Event Number
    Z-0279-2009
  • Event Initiated Date
    2008-08-20
  • Event Date Posted
    2008-10-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-12-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73246
  • 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
    Vascular Catheter - Product Code MCW
  • Reason
    The cordis lumend outback ltd re-entry catheter - separation rate of the cannula to the deployment slide of the handle assembly is higher than anticipated. the cannula is unable to be retracted into the device after deployment due to a separation of the inner key from the cannula.
  • Action
    U.S. Customers - A Notification of Recall Letter with an Acknowledgement Form was sent overnight to 5 individuals in each account on 08/18/2008. For non-U.S. customers, email notification with return acknowledgement is used to notify the affiliate distributors, who then notify and reconcile the customers in those countries (08/18/2008). Contact Cordis special Customer Service at (800) 551-7683 for assistance.

Device

Device Recall LuMend OUTBACK LTD
  • Model / Serial
    All lots
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide
  • Product Description
    Outback LTD Re-Entry Catheter, Sterile, Single Use. The Cordis LuMend OUTBACK LTD Re-Entry Catheter is indicated for placement and positioning of guidewires within the peripheral vasculature. The cannula is a nitinol needle that is used to re-enter the true lumen of the vessel.
  • Manufacturer
    Cordis Corporation

Manufacturer

Cordis Corporation
  • Manufacturer Address
    Cordis Corporation, 14201 NW 60th Avenue, Miami Lakes FL 33014
  • Manufacturer Parent Company (2017)
    Cardinal Health
  • Source
    USFDA