Cordis Dura Star RX and Fire Star RX PRCA Balloon Catheters Recall
Cordis Dura Star RX and Fire Star RX PRCA Balloon Catheters are balloon catheters that are used in a medical procedure to open narrowed or blocked blood vessels or arteries of the heart. They do this by opening up, like a balloon, to open these vessels and/or arteries. This product was found to have a potential slow deflation or no deflation of the angioplasty balloon when inserted into the artery or blood vessels. The following are potential dangers associated with this product:
- Total blockage of the artery or blood vessels
- Change in heart rate
- Change in heart rhythm
- Injury to the heart artery
- Heart attack
- Need for surgical procedure or death
Recall Information:
There has been a Class 1 Recall for Product: Fire Star™ RX and Dura Star™ RX PTCA Balloon Catheters manufactured by the Florida based Cordis Corporation. The concerned products were 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.
