—#67887

Product

CORDIS "Fire Star" 2.50 x 15 Dilatation Catheter, Catalog # 80115250, 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: 13187445 13191016 13191800 13197620 13197621 13200143 13200144 13200145 13218321 13221412 13221413 13222784 13224943 13224944 13230719 13235886 13237909 13246358 13247915 13252066 13253834 13265037 13268858 13279599 13281193 13281201 13281202 13281224 13281267 13281302 13281318 13281390 13281431 13281450 13282064 13283832 13284570 13285522 13288834 13289754 13292702 13293582 13293583 13295106 13298196 13304558 13306300 13307100 13310118 13310119 13313287 13313288 13318531 13320190 13321811 and 13324440

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 #67887. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.