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U.S. Department of Health and Human Services

Medical Devices

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Cordis Corporation Dura Star™ RX and Fire Star™ RX PTCA Balloon Catheters

Class 1 Recall
Date Recall
Initiated:
January 14, 2008
Product:

Fire Star™ RX and Dura Star™ RX PTCA Balloon Catheters

Products manufactured in Mexico from February, 2007 through December, 2007 and distributed worldwide from March 26, 2007 through January 8, 2008. Dura Star™ RX was distributed in the U.S. on August 29, 2007 and Fire Star™ RX was distributed in the U.S. on August 31, 2007.

All Fire Star™ and Dura Star™ lots 13173912 through 13315455, plus 52 additional lots above 13315455 are affected. (No lots above 13329055 are affected).

Use:

Balloon catheters are used in a medical procedure (known as percutaneous transluminal coronary angioplasty or PTCA) to open narrowed or blocked blood vessels or arteries of the heart.

Recalling Firm:

Cordis Corporation
14201 NW 60th Avenue
Miami Lakes, Florida 33014-2802

Reason for Recall:

The product has a potential for slow deflation or no deflation of the angioplasty balloon when inserted into the artery or other blood vessels. This may potentially result in a total blockage of the artery or blood vessels, resulting in a change in the heart rate or heart rhythm, injury to the heart artery, a heart attack, need for a surgical procedure or death.

Public Contact:
Consumers with questions may contact Cordis, Inc. at 1-786-313-2000.
FDA District:
Florida
FDA Comments:

On January 14, 2008, a letter and an acknowledgement form were mailed to U.S. customers with a Cordis representative following-up requesting a signature of receipt. For non-U.S. customers, an email notice was sent with return acknowledgment to notify their distributors, who then contacted their customers in those countries. The company has consulted with the FDA about disposing the products.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program.