The FDA warns about a dangerous heart device recall from Edwards Lifesciences after a patient died.

Oct 16, 2026, 11:15 AM ETProductRead the original at Benzinga

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Edwards recalled specific lots after 3 balloon-burst reports, including 1 death and 1 serious injury. Other lot numbers remain safe, but the severe harm and recall hurt the company's outlook.

EW · Edwards Lifesciences Corp.

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The affected systems help place replacement heart valves without open-chest surgery. Balloons burst in 3 reported procedures, and a trapped device can require more surgery. Other lots remain safe, limiting the recall's reach. Still, a death and a serious injury make this a serious setback for Edwards.

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