—#67352

Product

CORDIS "Dura Star" 2.50 x 15 Dilatation Catheter, Catalog # 70115250, Distributed by Cordis Corporation, Miami Lakes, FL 33014

FDA product code: LOX — Catheters, Transluminal Coronary Angioplasty, Percutaneous
Device class: Class 2
Medical specialty: Cardiovascular
PMA numbers: P880003
Affected lot / code info: Lot #s: 13175337 13180560 13183023 13195487 13195988 13207209 13209762 13209915 13209925 13211070 13216629 13217623 13222115 13250079 13250082 13255236 13255238 13271057 13275168 13277834 13278672 13285156 13290329 13291123 13298189 13298786 13300595 13303780 13305487 13310112 and 13314812

Why it was recalled

Slow Deflation or No Deflation

Root cause (FDA determination)

Process control

Action the firm took

Cordis initated the recall on 1/14/2008. For U.S. customers: An Urgent Medical Device Recall letter and an Acknowledgement Form was sent to the following 4 individuals in each account: Cath Lab Director, Operating Room Director, Materials Director, Risk Manager; to be followed up with direct Cordis representative contact to facilitate obtaining signature, faxing form, collecting and returning units. For non-US customers, email notification with return acknowledgement is used to notify the affiliate distributors, who then notify and reconcile the customers in those countries. All users were instructed to immediately set aside product and return it for replacement.

Recalling firm

Firm: Cordis Corporation
Address: 14201 NW 60th Avenue, Miami Lakes, Florida 33014-2802

Distribution

Distribution pattern: Worldwide.

Timeline

Recall initiated: 2008-01-14
Posted by FDA: 2008-02-06
Terminated: 2009-10-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #67352. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.