Cordis Corporation Dura Star™ RX and Fire Star™ RX PTCA Balloon Catheters are recalled
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.
All Fire Star™ and Dura Star™ lots 13173912 through 13315455, plus 52 additional lots above 13315455 are affected. (No lots above 13329055 are affected).
The 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.
The product was found to have a potential 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.
Since Class 1 recalls are serious recalls that involve situations in where there is a reasonable probability that use of the product will cause serious injury or death.
If you are a consumer or Health care professional and find adverse reactions or quality problems experienced with the use of this product, please contact the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.
Online:www.fda.gov/MedWatch/report.htm
Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm
Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
FAX: 1-800-FDA-0178
