Edwards Lifesciences recalls
8 official recalls and safety alerts involving Edwards Lifesciences since 2022-04, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Edwards Lifesciences or the relevant agency.
- 2026-05-20
USEdwards Lifesciences, LLC recalls Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO
Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.
FDA · DeviceEdwards Lifesciences, LLCWorldwide - US Nationwide distribution including in the states of AR, AZ, CA,…Official notice →- 2025-07-16
- US
Edwards Lifesciences, LLC recalls Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI16 Software Version: N/A…
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
FDA · DeviceEdwards Lifesciences, LLCWorldwide - US Nationwide distribution including in the states of ALABAMA,…Official notice → - 2023-12-06
- US
Edwards Lifesciences, LLC recalls 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.
FDA · DeviceEdwards Lifesciences, LLCUS: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO…Official notice → - 2023-11-15
- US
Edwards Lifesciences, LLC recalls Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35
Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds).
- 2023-09-06
- US
Edwards Lifesciences, LLC recalls PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000IS
Due to a manufacturing issue, when using valve repair systems, intended to repair insufficient mitral and/or tricuspid valves, users experienced resistance when attempting to release the implant from the delivery…
FDA · DeviceEdwards Lifesciences, LLCInternational distribution to the countries of Austria, Belgium, Switzerland,…Official notice → - 2023-04-19
- US
Edwards Lifesciences, LLC recalls Edward Lifesciences, REF 774F75, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 7.5F (2.5mm), Usable…
There is a potential that the distal end of the catheter may be bent beyond its intended curvature and when connected to patient monitoring device, the monitor may display an error message.
FDA · DeviceEdwards Lifesciences, LLCUS: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO…Official notice → - 2022-11-09
- US
Edwards Lifesciences, LLC recalls Fogarty Arterial Embolectomy Catheters Model Number: 120602FP 120403FP 120803FP 120404FP 120804FP 120805FP 120806FP 120807FP Fogarty…
Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches.
FDA · DeviceEdwards Lifesciences, LLCWorldwide distribution - U.S. Nationwide distribution including in the states…Official notice → - 2022-04-06
- US
Edwards Lifesciences, LLC recalls FORE-SIGHT ELITE Absolute Tissue Oximeter, REF: 01-06-3000, Contents: Monitor 1 EA., Accessory Kit 1 EA.
The StO2 values may be inaccurately low when using either the FORE-SIGHT ELITE Tissue Oximeter Module or the FORE-SIGHT ELITE Absolute Tissue Oximeter Monitor with the Fore-Sight Elite large sensor in certain somatic…
FDA · DeviceEdwards Lifesciences, LLCWorldwide distribution - US Nationwide distribution in the states of AK, AL,…Official notice →