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Date: 11/11/2009 11:53:32 AM

Edwards Lifesciences CardioVations EndoClamp Aortic Catheter - Class 1 Recall

REASON: The recall was initiated because the balloon catheters may spontaneously rupture during surgery.

distribution: nationwide.

Audience: Cardiovascular healthcare professionals, hospital risk managers

[Posted 11/09/2009] 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.

[11/09/2009 - Recall Notice - FDA]

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