FDA Recalls Edwards Lifesciences' CardioVations EndoClamp Aortic Catheter
November 10, 2009 – FDA and Edwards Lifesciences notified healthcare professionals this week about the class 1 FDA recall of CardioVations EndoClamp Aortic Catheter, due to the potential that the balloon catheters may spontaneously rupture during surgery.
The recall includes model numbers EC1001 and EC65. The device blocks off the aorta, monitors aortic pressure and delivers solution to stop the heart during cardiopulmonary bypass procedures. This product was manufactured from August 2008 through August 2009 and distributed from November 2008 through September 2009.
For more information: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm189650.htm