EW

Daveen Chopra

Known title: CVP, TMTT, Surgical & IHFMCIK: 0001740963

Associated companies

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October 17, 2026

EW: FDA Flags High-Risk Device Recall After Patient Death. The U.S. Food and Drug Administration flagged a potentially high-risk issue with Edwards Lifesciences' SAPIEN M3 delivery system, specifically the Commander M system, after a patient death was reported. The company has instructed customers to remove four specific lots of the device from use. This regulatory action highlights a significant safety concern for the company's key product line, drawing close regulatory scrutiny.

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Transaction History

EW▼ Sell$35K
EW▲ Buy$2.3M
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EW▼ Sell$30K
EW▲ Buy$0

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