The Cordis unit was recalled Friday after the Food and Drug Administration determined the product could lead to a heart attack, surgery or death.
The Class 1 recall, the most serious type of recall, affects Cordis’ 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, 2008. The FDA issued a notice on its Web site Friday.
‘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.