On November 11, 2009, the US Food And Drug Administration (FDA) issued a Class 1 recall of CardioVations EndoClamp Aortic Catheters, manufactured by Edwards Lifesciences. The device, which is used during some bypass surgeries, has been recalled by the federal government and the biotech company because the catheters have been reported to rupture or burst during heart surgery. The product was manufactured and sold since August of 2008. The model numbers involved in the medical device recall are EC1001 and EC65.

The company urges medical professionals to search their inventory for the defective medical devices and ship them back to the company. Health professionals should also report any adverse events involving Edwards Lifesciences medical devices – or any defective medical devices – to the FDA.

Class I recalls are the most serious form of FDA recalls and take place when a medical device may cause serious injury or death when they are used.