Filing Flows › Edwards Lifesciences (EW) › Recalls, complaints & regulation
Edwards Lifesciences (EW): recalls, EPA violations, clinical trials and Federal Register
Edwards Lifesciences (EW) beyond its filings: 1 recall in the last 12 months (21 in five years, 6 Class I); 0 EPA-regulated facilities in violation, $500K in penalties over five years; 3 Federal Register documents in a year; 45 active clinical trials.
Latest recalls
- 2026-05-20 · FDA device · Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO
- 2025-07-16 · FDA device · Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI16 Software Version: N/A Product Description: Cardia
- 2025-07-16 · FDA device · Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016AS Software Version: N/A Product Description: The Edwards FEMFL
- 2025-07-16 · FDA device · Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018A Software Version: N/A Product Description: The Edwards FEMFLE
- 2025-07-16 · FDA device · Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016A Software Version: N/A Product Description: The Edwards FEMFLE
- 2025-07-16 · FDA device · Brand Name: FEM-FLEXII Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018AS Software Version: N/A Product Description: The Edwards FEMFLE
- 2025-07-16 · FDA device · Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI18 Software Version: N/A Product Description: Cardia
- 2023-12-06 · FDA device · Acumen IQ Sensor with VAMP System, REFs: AIQS6AZ & AIQS6AZ5, STERILEEO, Rx only. For use in intravascular pressure monitoring.
Edwards Lifesciences' latest quarter
Edwards Lifesciences, Q3 2026: revenue $1.7B (+10% year over year), operating margin 17.4%, net earnings $308M, operating cash flow $570M. The chart follows the revenue to costs, profit and cash.
Questions
Has Edwards Lifesciences had any recalls?
21 recalls on file over five years from the FDA, CPSC and NHTSA; 1 in the last 12 months.
Has Edwards Lifesciences been fined by the EPA?
The 17 EPA-regulated facilities on file under its name drew $500K in penalties over five years; 0 are in violation now.
How many clinical trials does Edwards Lifesciences have?
45 active studies on ClinicalTrials.gov, 0 in phase 3.
Updated Nov 8, 2026. Read automatically from SEC filings and public data; errors are possible. Not investment advice.