Z-0279-2009

Outback LTD Re-Entry Catheter, Sterile, Single Use. The Cordis LuMend OUTBACK LTD Re-Entry Catheter is...

Name: Z-0279-2009 Outback LTD Re-Entry Catheter, Sterile, Single Use. The Cordis LuMend OUTBACK LTD Re-Entry Catheter is...
Creator: Cordis Corporation
Published: 2008-08-20
License: https://open.fda.gov/license/

Cordis US Corp. / initiated 2008-08-20 / Terminated

FDA source

Cordis Corporation began a recall of Outback LTD Re-Entry Catheter, Sterile, Single Use. The Cordis LuMend OUTBACK LTD Re-Entry Catheter is indicated for placement and positioning of guidewires... on 2008-08-20. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0279-2009
Status: Terminated
Initiated: 2008-08-20
Posted: 2008-10-31
Terminated: 2008-12-01
Recalling firm: Cordis US Corp.
Product: 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.
Product code: MCW Catheter, Peripheral, Atherectomy
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.
FDA root cause: Other
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.
Quantity in commerce: 11,893
Distribution: Worldwide
Product codes and lots: All lots

Product code MCW

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)