Overview of recall records associated with Edwards Lifesciences, LLC, including dates, categories and classifications where available.
Classification mix: Class II: 34, Class I: 18.
Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
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…
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.
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.
Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches.
Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches.
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…
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…
There is a potential for internal leaks within catheters.
There is a potential for internal leaks within catheters.
There is a potential for internal leaks within catheters.
There is a potential for internal leaks within catheters.
This page summarizes recall records in which the official source identifies Edwards Lifesciences, LLC as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.
