Edwards Lifesciences Llc
ONE EDWARDS WAY, IRVINE, CA, US
Registered product codes
23 product codes
Recent MDR events
7,567 on file
- Edwards INSPIRIS RESILIA Aortic ValveJul 31, 2026Injury2015691-2026-17322
- Carpentier-Edwards PERIMOUNT Magna Mitral Ease Pericardial BioprosthesisJul 28, 2026Injury2015691-2026-17203
- CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS - AORTICJul 28, 2026Malfunction50053696
- Edwards SAPIEN 3 Transcatheter Heart ValveJul 28, 2026Injury2015691-2026-17206
- Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart ValveJul 28, 2026Injury2015691-2026-17223
- SAPIEN Transcatheter Heart Valve System and accessoriesJul 28, 2026Death2015691-2026-17077
- Edwards eSheath Introducer SetJul 28, 2026Death2015691-2026-17075
- SAPIEN Transcatheter Heart Valve System and accessoriesJul 28, 2026Death2015691-2026-17079
- Edwards eSheath Introducer SetJul 28, 2026Injury2015691-2026-17074
- SAPIEN Transcatheter Heart Valve System and accessoriesJul 28, 2026Injury2015691-2026-17078
Recalls
169 on file
- Open, ClassifiedMay 13, 2026
Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.
View FDA record ↗ - Open, ClassifiedJul 10, 2025
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
View FDA record ↗ - Open, ClassifiedJul 10, 2025
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
View FDA record ↗ - Open, ClassifiedJul 10, 2025
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
View FDA record ↗ - Open, ClassifiedJul 10, 2025
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
View FDA record ↗ - Open, ClassifiedJul 10, 2025
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
View FDA record ↗ - Open, ClassifiedJul 10, 2025
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
View FDA record ↗ - Open, ClassifiedNov 29, 2023
Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
View FDA record ↗ - Open, ClassifiedNov 29, 2023
Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
View FDA record ↗ - Open, ClassifiedNov 29, 2023
Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
View FDA record ↗
Compliance history
Matched by FEI 2015691.
FDA inspections
1 on file
- No Action Indicated (NAI)Aug 15, 2024
Bioresearch Monitoring
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.