Edwards Lifesciences recalls delivery system for Sapien heart valves [Reuters (UK)]
Edwards Lifesciences Corporation (EW)
Last edwards lifesciences corporation earnings: 4/23 04:15 pm
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Source: Reuters
Edwards Lifesciences recalls delivery system for Sapien heart valves - Reuters 1 Min Read (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 All quotes delayed a minimum of 15 minutes. See here for a complete list of exchanges and delays. Š 2019 Reuters. All Rights Reserved.
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EW
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- 2/6/24 - In-Line
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- 4/9/24 - Form 4
- 4/9/24 - Form 144
- 4/8/24 - Form 4
- EW's page on the SEC website