JOHNSON & JOHNSON CORDIS CATHETERS RECALLED

January 14, 2008: Johnson & Johnson initiated a recall of more than 130,000 balloon catheters used in surgery to clear arteries clogged with plaque.

Background:

Johnson& Johnson recalled Cordis balloon catheters used in angioplasties following reports that the defective medical device had injured two people. The Fire Star-RX and Dura Star-RX PTCA balloon catheters have the 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 heart rate or rhythm, injury to the heart artery, a heart attack, need for surgical procedure or death. For these reasons, the Food & Drug Administration (FDA) has placed a Class I recall on the Johnson & Johnson Cordis balloon catheter. Class I 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.

Balloon catheters are used during medical procedures to open narrowed or blocked blood vessels or arteries of the heart. According to FDA recall, the recalled Cordis balloon catheters were manufactured in Mexico from February, 2007 through December, 2007 and distributed worldwide from March 26, 2007 through January 8, 2008. Dura Star RX balloon catheters were distributed in the U.S. on August 29, 2007 and Fire Star RX balloon catheters were 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).

On January 14, 2008, a letter and an acknowledgement form were mailed to U.S. customers informing them of the recall. Cordis representatives also were instructed to follow-up with customers in order to request 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.

What can I do?

If you have experienced any adverse effects from a Cordis balloon catheter, you should immediately consult your physician. You may also want to consider your potential legal claim. If you would like more information, click here to fill out a free case review form or contact attorney Ron Goldser directly, toll-free at 800.755.0098. Zimmerman Reed is experienced in handling defective medical device cases and we welcome any questions you may have.