The FDA along with Cordis Corporation have issued a Class I recall of All Fire Star and Dura Star balloon catheters.

The defective medical device lots recalled are13173912 through 13315455, plus 52 additional lots above 13315455. 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.

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.

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.

Consumers with questions may contact Cordis, Inc. at 1-786-313-2000

For Legal Questions and assistance call 1-866-242-0905 or visit the Fire Star Recall section.

Consumer Alerts, Defective Products, Recalls