August 22, 2019 / 3:47 PM / 7 months ago

Edwards Lifesciences recalls delivery system for Sapien heart valves

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 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. (Reporting by Manojna Maddipatla in Bengaluru; Editing by Shinjini Ganguli)

0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below