Edwards Lifesciences Recalls Catheter

Edwards Lifesciences is recalling two models of its CardioVations endoclamp aortic catheter, an action the FDA considers a Class I recall. The device blocks off the aorta, monitors aortic pressure and delivers a solution to stop the heart during cardiopulmonary bypass procedures. The affected devices were distributed from November 2008 through September and are being recalled because the balloon catheters may spontaneously rupture during surgery, according to an FDA statement.