—#73246

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.

FDA product code: MCW — Catheter, Peripheral, Atherectomy
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K001577, K014117, K032298, K040771, K043534
Affected lot / code info: All lots

Why it was recalled

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 (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Cordis Corporation
Address: 14201 NW 60th Avenue, Miami Lakes, Florida 33014

Distribution

Distribution pattern: Worldwide

Timeline

Recall initiated: 2008-08-20
Posted by FDA: 2008-10-31
Terminated: 2008-12-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #73246. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.