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-0.000323624595469224 -0.000531668978270962 0.000647249190938448 0.00120203421174291 0.000531668978270831 0.00134073046694402 0.00171058714748037 0.00171058714748037
Stock impact report

UPDATE 1-FDA classifies Edwards Lifesciences Sapien delivery system recall as severest [Reuters]

Edwards Lifesciences Corporation (EW) 
Last edwards lifesciences corporation earnings: 4/23 04:15 pm Check Earnings Report
US:NYSE Investor Relations: ir.edwards.com
Company Research Source: Reuters
UPDATE 1-FDA classifies Edwards Lifesciences Sapien delivery system recall as severest (Adds background, share movement and analyst comment) Aug 22 (Reuters) - 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. The FDA uses the term “recall” when a manufacturer takes a corrective action or removes a problematic a medical device from market that violates its law. A recall does not always mean that customers must stop using the product or return it to the company. The agency said that burst ball Show less Read more
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