CardioVations EndoClamp Aortic Catheters are being recalled by Edwards Lifesciences Corporation. According to the recall notice, the balloon catheters may spontaneously rupture during surgery.
The Food & Drug Administration (FDA) has deemed this a Class I recall, its most serious type of recall. Such recalls involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
The CardioVations EndoClamp Aortic Catheters subject to this recall include Model Numbers EC1001 and EC65. This product was manufactured from August, 2008 through August, 2009 and distributed from November, 2008 through September, 2009.
On October 29 , 2009, Edwards Lifesciences sent a letter to their customers instructing them to:
Check their inventory and identify any unused product
Return unused products to the company
The CardioVations EndoClamp Aortic Catheter locks off the aorta, monitors aortic pressure, and delivers solution to stop the heart during cardiopulmonary bypass procedures.
