The federal government and the makers of a catheter balloon commonly used in heart surgeries have issued an urgent recall, announcing that the balloons could suddenly burst during surgery.

The CardioVations EndoClamp Aortic Catheters pose a life-threatening safety risk to patients as they may suddenly burst during heart surgery, according to the Food and Drug Administration.

The New York City medical malpractice lawyers at Queller, Fisher, Washor, Fuchs & Kool represent heart patients who were improperly diagnosed or suffer complications during surgery as a result of surgical negligence, malpractice or defective medical devices.


The FDA and Edwards Lifesciences Corp., the maker of the devices, ordered the Class I recall for CardioVations EndoClamp Aortic Catheter, model numbers EC1001 and EC65. A Class I recall is the nation's most serious recall, aimed at products with a reasonable probability of causing serious injury or death.

The CardioVations EndoClamp Aortic Catheter is a balloon catheter used to block the aorta, monitor pressure and, when necessary, stop the heart during bypass surgery, according to the FDA. The devices were manufactured between Aug. 2008 and Aug. 2009 and distributed to hospitals through this September.

Initially recalled in September, the FDA issued a new warning last week telling hospitals to re-check hospital inventory and return defective catheters to the manufacturer.