Edwards Lifesciences recalls delivery system for Sapien heart valves

 

(Reuters) – Medical device maker Edwards Lifesciences Corp is recalling its Sapien 3 Ultra delivery system after burst balloons during implantation led to several injuries and a death, said the U.S. Food and Drug Administration on Thursday.

Shares of the company fell 4% to $212.33.

The FDA said it was a Class I recall, the severest form of recall. “Use of these devices may cause serious injuries or death,” the agency said.

The delivery system is used to deploy its Sapien 3 Ultra transcatheter heart valve to replace a diseased aortic valve without open-heart surgery.