—#67354

Product

CORDIS "Dura Star" 3.00 x 15 Dilatation Catheter, Catalog # 70115300, 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: 13173912 13182671 13185355 13189430 13190065 13207021 13207210 13208754 13209926 13211071 13217625 13266340 13267868 13270374 13271060 13274855 13275193 13277836 13278673 13279268 13279925 13279926 13286195 13286196 13291890 13297294 13298787 13300601 13300606 13302299 13306282 13310114 13310115 13313280 13314813 and 13315455

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 #67354. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.