Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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.

FDA Recall Z-0279-2009 · Posted 2008-10-31

Recalling FirmCordis Corporation
Recall StatusTerminated
Product CodeMCW
Date Initiated2008-08-20
Date Terminated2008-12-01
Product Quantity11,893

Reason for Recall

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.

Firm 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.

Root Cause

Other

Distribution Pattern

Worldwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K043534MODIFICATION TO OUTBACK CATHETERLumend, Inc. · 2005-01-21K040771MODIFICATION TO OUTBACK CATHETERLumend, Inc. · 2004-04-23K032298MODIFICATION TO OUTBACK CATHETERLumend, Inc. · 2003-08-26K014117MODIFICATION TO OUTBACK CATHETERLumend, Inc. · 2002-01-11K001577OUTBACK CATHETERLumend, Inc. · 2001-01-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑