FDA Recall Warning - Balloon Catheters
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(866) 735-1102 Ext 335
The FDA and Cordis Corporation today announced a recall of balloon catheters due to defects in their ability to do what they are designed to do. This product was manufactured in Mexico. Fire Star and Dura Star Balloon Catheters are designed to be inserted into arteries and vessels that are partially blocked. This allows the blood to more freely flow and is associated with prolonging life or the quality of life. From the FDA's report, Class 1 Recall: Cordis Corporation Dura Starâ„¢ RX and Fire Starâ„¢ RX PTCA Balloon Catheters, the product has the possibility for slow deflation or no deflation of the angioplasty balloon and can lead to 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.
Product: Fire Starâ„¢ RX and Dura Starâ„¢ 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 Starâ„¢ RX was distributed in the U.S. on August 29, 2007 and Fire Starâ„¢ RX was distributed in the U.S. on August 31, 2007.
All Fire Starâ„¢ and Dura Starâ„¢ lots 13173912 through 13315455, plus 52 additional lots above 13315455 are affected. (No lots above 13329055 are affected).
Contact the Recalling Firm: Cordis Corporation, 14201 NW 60th Avenue, Miami Lakes, Florida 33014-2802. Cordis is a Johnson & Johnson subsidiary.
Public Contact: Consumers with questions may contact Cordis, Inc. at 1-786-313-2000.