Recall Z-0279-2009 ยท MCW Catheter, Peripheral, Atherectomy
Cordis Corporation
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.
| Date | Oct 31, 2008 (initiated Aug 20, 2008) |
| Status | Terminated |
| 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. |
| 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 | 11,893 |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001577 | OUTBACK CATHETER Lumend, Inc., Jan 11, 2001 |
| K014117 | MODIFICATION TO OUTBACK CATHETER Lumend, Inc., Jan 11, 2002 |
| K032298 | MODIFICATION TO OUTBACK CATHETER Lumend, Inc., Aug 26, 2003 |
| K040771 | MODIFICATION TO OUTBACK CATHETER Lumend, Inc., Apr 23, 2004 |
| K043534 | MODIFICATION TO OUTBACK CATHETER Lumend, Inc., Jan 21, 2005 |