FDA classifies Edwards Lifesciences Sapien delivery system recall as severest

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REUTERS: The U.S. Food and Drug Administration said on Thursday the recall of Edwards Lifesciences Corp's Sapien 3 Ultra delivery system was ...

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 3per cent.

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. Edwards initiated the corrective action in July after receiving reports of 17 injuries and one death.The recall affects 1,585 heart valve delivery systems, the FDA said. However, Edwards said the recall was immaterial to the company's revenue forecast.

 

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