Johnson & Johnson has recalled balloon catheters used in angioplasties following reports that the defective medical devices injured two people. The Fire Star-RX and Dura Star-RX PTCA balloon catheters, which are manufactured by Johnson & Johnson’s Cordis unit, do not deflate properly and could potentially cause fatal injuries. For that reason, the Food & Drug Administration (FDA) has deemed the Johnson & Johnson Cordis balloon catheter recall a Class I recall. 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 in a medical procedure (known as percutaneous transluminal coronary angioplasty or PTCA) to open narrowed or blocked blood vessels or arteries of the heart. According to FDA alert, 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 catheter 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 defective Cordis balloon catheters have 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.
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.
Customers about the Johnson & Johnson balloon catheter recall can contact Cordis, Inc. at 1-786-313-2000.
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