Class I Recall Initiated for Aortic Catheter
Edwards Lifesciences Corporation notified its customers about a class I recall of its CardioVations EndoClamp Aortic Catheter. The devices involved in the recall were distributed from November 2008 through September 2009. The model numbers included in the recall are:
The EndoClamp catheter is an important piece of equipment used during heart bypass surgery. The device blocks the aortic artery, delivers the solution that stops the heart during surgery, and monitors the aortic blood pressure. The problem is identified as a potential for the balloon catheters to burst spontaneously causing catastrophic and life threatening emergencies.
Obviously, heart bypass surgery is risky enough without introducing a life-threatening defect to one of the key components. Due to the severe nature of the defect and the potentially grave situation that may develop, the recall is classified as a Class I, the most serious type of recall on dangerous medical devices.
Healthcare facilities that use this product should isolate the remaining devices and contact Edwards Lifescience Corporation immediately to find out how to return the product. The customer phone number is, at 1-800-424-3278.
If you lost a loved one during a heart bypass surgery, it may be a result of a defective product like the CardiVations EndoClamp Aortic Catheter. If you suspect that this device contributed to the death of your loved one, please contact the experienced product liability attorneys at Schlichter, Bogard & Denton, LLP who work with clients nationwide.