—#67890

Product

CORDIS "Fire Star" 3.00 x 15 Dilatation Catheter, Catalog # 80115300, 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: 13187446 13191355 13197622 13200865 13214556 13221415 13223385 13225878 13231289 13236340 13239277 13247916 13261565 13264549 13268859 13279605 13280401 13280405 13281186 13281219 13281279 13281314 13281364 13281432 13281451 13282065 13284571 13287298 13292703 13293584 13295107 13304559 13306306 13309113 13314818 13315461 13317743 and 13321813

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 #67890. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.