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Edwards Lifesciences, LLC

Edwards Lifesciences, LLC Recalls

All product recalls associated with Edwards Lifesciences, LLC.

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Recall Summary

Total Recalls

60

Past Year

3

Class I (Serious)

0

Most Recent

May 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–20 of 60 recalls

FEM-FLEX II Arterial Cannula (Edwards) – Wire Exposure (2025)

due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.

FDAMay 14, 2025Nationwide• Edwards Lifesciences, LLC

Optisite Arterial Cannula (Edwards) – Wire Exposure (2025)

due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.

FDAMay 14, 2025Nationwide• Edwards Lifesciences, LLC

FEM-FLEXII Arterial Cannula (Edwards) – Wire Exposure (2025)

due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.

FDAMay 14, 2025Nationwide

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• Edwards Lifesciences, LLC

Edwards Lifesciences, LLC: FloTrac Sensor, REF: MHD8 & MHD85,MHD6R5, MHD8R, MHD8R5, ...

Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.

FDAOct 4, 2023AL, AK, AZ +48 more• Edwards Lifesciences, LLC

Edwards Lifesciences, LLC: TruWave with Vamp System Pressure monitoring set, REF: P...

Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.

FDAOct 4, 2023AL, AK, AZ +48 more• Edwards Lifesciences, LLC

Edwards Lifesciences, LLC: Acumen IQ Sensor, REFs: AIQS6, AIQS65, AIQS6R, AIQS6R5, A...

Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.

FDAOct 4, 2023AL, AK, AZ +48 more• Edwards Lifesciences, LLC

Edwards Lifesciences, LLC: TruWave Pressure monitoring set, REF: PX212: cc/12 in (30...

Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.

FDAOct 4, 2023AL, AK, AZ +48 more• Edwards Lifesciences, LLC

Edwards Lifesciences, LLC: Acumen IQ Sensor with VAMP System, REFs: AIQS6AZ & AIQS6A...

Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.

FDAOct 4, 2023AL, AK, AZ +48 more• Edwards Lifesciences, LLC

Edwards Lifesciences, LLC: FloTrac Sensor with Vamp System, REF: MHD6AZ, MHD6AZ5 , M...

Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.

FDAOct 4, 2023AL, AK, AZ +48 more• Edwards Lifesciences, LLC

Edwards Lifesciences, LLC: Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35

Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds).

FDASep 7, 2023Nationwide• Edwards Lifesciences, LLC

Edwards Lifesciences, LLC: PASCAL Precision Transcatheter Valve Repair System, Model...

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 system by rotating the release knob. Additional torque required to initiate rotation of the release wire from the implant, could cause implant rotation or additional implant implantation.

FDAJul 27, 2023Nationwide• Edwards Lifesciences, LLC

Edwards Lifesciences, LLC: Edward Lifesciences, REF 777F8, Swan-Ganz CCOmbo V, CCO/S...

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.

FDAFeb 14, 2023AL, AK, AZ +47 more• Edwards Lifesciences, LLC

Edwards Lifesciences, LLC: Edward Lifesciences, REF 774F75, Swan-Ganz CCOmbo V, CCO/...

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.

FDAFeb 14, 2023AL, AK, AZ +47 more• Edwards Lifesciences, LLC

Edwards Lifesciences, LLC: Fogarty Arterial Embolectomy Catheters Model Number: 1206...

Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches.

FDAOct 6, 2022Nationwide• Edwards Lifesciences, LLC

Edwards Lifesciences, LLC: Fogarty Biliary Balloon Probes Model Number: 410235FP 410...

Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches.

FDAOct 6, 2022Nationwide• Edwards Lifesciences, LLC

Edwards Lifesciences, LLC: FORE-SIGHT ELITE Tissue Oximeter module, REF: HEMFSM10

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 locations (arms and legs). While the StO2 absolute values are impacted, the directional trend remains accurate, but may have a larger magnitude change. Low StO2 values may lead to unintended or inappropriate treatment

FDAMar 1, 2022Nationwide• Edwards Lifesciences, LLC

Edwards Lifesciences, LLC: FORE-SIGHT ELITE Absolute Tissue Oximeter, REF: 01-06-30...

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 locations (arms and legs). While the StO2 absolute values are impacted, the directional trend remains accurate, but may have a larger magnitude change. Low StO2 values may lead to unintended or inappropriate treatment

FDAMar 1, 2022Nationwide• Edwards Lifesciences, LLC

Edwards Lifesciences, LLC: Edwards PediaSat Oximetry Catheter Kit, REF: XT3515KTP, E...

There is a potential for internal leaks within catheters.

FDAJul 9, 2021AZ, CA, FL +9 more• Edwards Lifesciences, LLC

Edwards Lifesciences, LLC: Edwards TruWave x 2 (3 cc)/VAMP Jr/54 in (136) Kit, REF:...

There is a potential that the pressure tubing may detach from the blood sampling system

FDAMay 26, 2021AZ, CA, CO +30 more• Edwards Lifesciences, LLC

Edwards Lifesciences, LLC: Edwards TruWave (30 cc)/VAMP Jr/52 in (132 cm) Kit, REF: ...

There is a potential that the pressure tubing may detach from the blood sampling system

FDAMay 26, 2021AZ, CA, CO +30 more• Edwards Lifesciences, LLC