—#67883

Product

CORDIS "Fire Star" 2.00 x 15, Dual Marker Band, Dilatation Catheter, Catalog # 8011520D, 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: 13187444 13191354 13191804 13191806 13197619 13199595 13211692 13214551 13218320 13221410 13221411 13224181 13224183 13227940 13229366 13230718 13237908 13242132 13244057 13246357 13247914 13251133 13255710 13262746 13268852 13281396 13281411 13282063 13283824 13283830 13283831 13284569 13285521 13288833 13289751 13291895 13295105 13297306 13301370 13304557 13309111 13313286 13316796 13321809 and 13323516

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 #67883. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.