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Edwards Lifesciences

EW NYSE

Medicare add-on payments

New: 1
Continued: 1
Lost: 0

Edwards Lifesciences: technologies on the Medicare add-on payment list
Status	Technology	Max add-on payment	Implied cost per case
New	SAPIEN M3 Transcatheter Mitral Valve Replacement System	$35,100	$54,000
Continued	Edwards EVOQUE Tricuspid Valve Replacement System	$31,850	$49,000

FDA device recalls, last 36 months

FDA data as of September 30, 2026. Source: openFDA.

FDA device recalls, most serious first
Class	Product	Reason	Initiated	FDA record
Class I	Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI16 Software Version: N/A Product Description:…+5 more products	due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.	May 14, 2025	FDA record
Class II	Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO	Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.	Mar 27, 2026	FDA record