The U.S. Food and Drug Administration said on Thursday the recall of Edwards Lifesciences Corp’s Sapien 3 Ultra delivery system was classified as the agency’s severest, sending shares of the medical device maker down 3%. The system is used to deliver and deploy a transcatheter heart valve to replace a diseased aortic valve without open-heart surgery. In July, Edwards sent a safety notice to customers and doctors, recommending that the balloon in the delivery system be inflated slowly and continuously when deploying heart valve, to avoid rupture.

source https://finance.yahoo.com/news/1-fda-classifies-edwards-lifesciences-184732970.html?.tsrc=rss