—#67876

Product

CORDIS "Fire Star" 2.50 x 10 Dilatation Catheter, Catalog # 80110250, 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: 13191352 13191802 13199593 13203919 13214549 13215774 13222780 13230715 13237699 13239273 13263486 13267187 13281191 13281255 13281337 13281339 13281340 13281346 13281370 13281430 13291894 13292697 13293579 13295103 13298195 13304556 13305489 13305490 13309109 13313285 13314815 and 13319351

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 #67876. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.