Edwards Lifesciences LLC
FDA adverse event reports naming Edwards Lifesciences LLC as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: EDWARDS LIFESCIENCES LLC.
- Total reports
- 7,109
- Deaths
- 1,295
- Injuries
- 4,997
- Malfunctions
- 807
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Aortic Valve, Prosthesis, Percutaneously DeliveredNPT3,611
- Replacement Heart-ValveDYE1,065
- Introducer, CatheterDYB924
- Prosthesis, Mitral Valve, Percutaneously DeliveredNPU630
- Heart-Valve, Non-Allograft TissueLWR379
- Catheter, Flow DirectedDYG156
- Catheter, Intravascular, DiagnosticDQO61
- Transducer, Pressure, Catheter TipDXO53
- Catheter, EmbolectomyDXE51
- Catheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassDWF31
Recent recalls
- 2026-05-13Open, ClassifiedLabeling design
Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO
Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.
- 2025-07-10Open, ClassifiedUnder Investigation by firm
Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI16 Software Version: N/A Product Description: Cardiac cannula. The Edwards OptiSite Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No.
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
- 2025-07-10Open, ClassifiedUnder Investigation by firm
Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI18 Software Version: N/A Product Description: Cardiac cannula. The Edwards OptiSite Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
- 2025-07-10Open, ClassifiedUnder Investigation by firm
Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016A Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
- 2025-07-10Open, ClassifiedUnder Investigation by firm
Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016AS Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
- 2025-07-10Open, ClassifiedUnder Investigation by firm
Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018A Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
- 2025-07-10Open, ClassifiedUnder Investigation by firm
Brand Name: FEM-FLEXII Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018AS Software Version: N/A Product Description: The Edwards FEMFLEXII Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
- 2023-11-29Open, ClassifiedDevice Design
Acumen IQ Sensor, REFs: AIQS6, AIQS65, AIQS6R, AIQS6R5, AIQS8, AIQS85, AIQS8R5, Rx only, Sterile EO. For use in intravascular pressure monitoring.
Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
- 2023-11-29Open, ClassifiedDevice Design
Acumen IQ Sensor with VAMP System, REFs: AIQS6AZ & AIQS6AZ5, STERILEEO, Rx only. For use in intravascular pressure monitoring.
Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
- 2023-11-29Open, ClassifiedDevice Design
FloTrac Sensor, REF: MHD8 & MHD85,MHD6R5, MHD8R, MHD8R5, MHD8S, STERILEEO, Rx only. For use in intravascular pressure monitoring.
Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
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