Edwards Lifesciences gets FDA warning letter

Edwards Lifesciences gets FDA warning letter for heart surgery product facility in Utah

Associated Press

IRVINE, Calif. (AP) -- Edwards Lifesciences Corp. said Wednesday that it received a warning letter from the Food and Drug Administration regarding a facility that makes products used in heart surgery. The FDA won't approve devices that could be affected by those issues until the problems are resolved.

The warning is related to quality issues with its cardiac surgery systems division and a Draper, Utah, facility. The company said the FDA raised concerns about design validation, about its ability to prevent and correct problems, and device packaging, among other issues. The Draper facility makes products including catheters used in cardioplegia procedures, or surgeries in which the heart is intentionally stopped. It also makes components for Edwards' transcatheter heart valves and heart valve repair rings.

Edwards does not expect the warning to affect its guidance this year and said it has begun responses to address the FDA's criticisms.

Shares closed down 97 cents to $64.22.

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