Edwards Lifesciences CardioVations EndoClamp Aortic Catheter - Class 1 Recall:Product, used during cardiopulmonary bypass procedures, may spontaneously rupture during surgery

[FDA MedWatch <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Edwards Lifesciences CardioVations EndoClamp Aortic Catheter - Class 1 Recall:Product, used during cardiopulmonary bypass procedures, may spontaneously rupture during surgery

Edwards Lifesciences CardioVations EndoClamp Aortic Catheter - Class 1 Recall

Audience: Cardiovascular healthcare professionals, hospital risk managers

FDA and Edwards Lifesciences notified healthcare professionals about the Class 1 recall of CardioVations EndoClamp Aortic Catheter, Model Numbers EC1001 and EC65, a device that blocks off the aorta, monitors aortic pressure, and delivers solution to stop the heart during cardiopulmonary bypass procedures. The recall was initiated because the balloon catheters may spontaneously rupture during surgery. This product was manufactured from August, 2008 through August, 2009 and distributed from November, 2008 through September, 2009. 

Read the complete MedWatch 2009 Safety summary, including a link to the Class 1 recall notice, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm189650.htm

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