Edwards Lifesciences Shares Fall As FDA Reports Recall Of Sapien 3 Ultra

The Food and Drug Administration reported Edwards Lifesciences EW has recalled Sapien 3 Ultra delivery system due to burst balloons during surgery.

Reports first emerged in June that the company had issued a field safety notice regarding its Sapien 3 Ultra system for transcatheter aortic valve replacement (TAVR), warning physicians it has received reports of burst balloons.

This burst balloons may result in vascular injury, bleeding, or surgical intervention.

Edwards Lifesciences shares were trading down 3% to $215 at time of publication. The stock has a 52-week high of $226.41 and a 52-week low of $136.44.

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