|Cordis’ Dura Star Rx PTCA Dilation Catheter. Source: Cordis|
Cordis, a Johnson & Johnson (J &J) subsidiary, has recalled certain balloon catheters after the FDA determined the products could lead to a heart attack, surgery or death.
Cordis said the Class 1 recall, the most serious type of recall, affects its Dura Star RX PTCA and Fire Star RX balloon catheters. The products were manufactured in Mexico from February 2007 to December 2007 and distributed worldwide from March 26, 2007, through Jan. 8, according to the Miami Lakes, Fla.-based Cordis.
On Jan. 14, a letter and an acknowledgement form were mailed to U.S. customers informing them of the recall, the company said. Cordis representatives also were instructed by the FDA 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. Cordis said that it has also consulted with the FDA about disposing the products.
The FDA issued a notice on its website on Jan. 25.
“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,” according to the agency.