Aug 22 (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 ...

A problem with bursting balloons with the Sapien 3 Ultra transcatheter heart valve delivery system (Edwards Lifesciences), previously reported by TCTMD, has now been identified as a class I recall by ...

(Reuters) - The U.S. health regulator on Thursday categorized the recall of Edwards Lifesciences Corp's Sapien 3 Ultra delivery system as extremely serious, highlighting health risks associated with ...

FDA has classified its recent recall of Edwards Lifesciences’ (NYSE:EW) Sapien 3 Ultra delivery system as Class I due to health risks associated with its use. However, the products will remain in the ...

IRVINE, Calif.--(BUSINESS WIRE)--Edwards Lifesciences Corporation (NYSE: EW) today announced the company’s SAPIEN M3 mitral valve replacement system received CE Mark for the transcatheter treatment of ...