ENDOCLAMP AORTIC CATHETER RECALLED – MAY CAUSE DEATH
Edwards Lifesciences Corporation has issued a recall for CardioVations EndoClamp Aortic Catheters. The subject recall includes CardioVations EndoClamp Aortic Catheters manufactured from August 2008 through August 2009 and distributed between November 2008 and September 2009. The FDA has classified the recall as a Class I Recall. FDA Class I Recalls inlcude dangerous of defective products tha predictabily could casue serious injury or death.
The medical device is used during heart bypass surgery to block off the aorta, monitor aortic pressure and deliver solution to stop the heart during cardiopulmonary bypass procedures. There is a risk that the balloon catheters may spontaneously rupture during the heart bypass surgery and cause death. FDA RECALL CLASSIFICATIONS
The manufacturer began to contact its customers on October 29, 2009 and asked its customers to check their inventory and identify unused product. Also the manufacturer has asked its customers to return unused aortic catheters to the manufacturer. The recall includes aortic catheter Model Numbers EC1001 and EC65.
It is unknown at this time how many of the subject aortic catheters were used in patients between November 2008 and September 2009, but if you or a loved one had heart bypass surgery during this time period and suffered serious injury or death Edwards Lifesciences Corporation’s aortic catheter may have caused the adverse affects or death. Our law firm is committed to protecting the rights of the injured. Contact one of our medical device attorneys today for a free legal consultation.