Overview of recall records associated with Edwards Lifesciences, LLC, including dates, categories and classifications where available.
Classification mix: Class II: 34, Class I: 18.
There is a potential for internal leaks within catheters.
There is a potential for internal leaks within catheters.
There is a potential that the pressure tubing may detach from the blood sampling system
There is a potential that the pressure tubing may detach from the blood sampling system
There is a potential that the pressure tubing may detach from the blood sampling system
There is a potential that the pressure tubing may detach from the blood sampling system
There is a potential that the pressure tubing may detach from the blood sampling system
There is a potential that the pressure tubing may detach from the blood sampling system
There is a potential that the pressure tubing may detach from the blood sampling system
There is a potential that the pressure tubing may detach from the blood sampling system
Intermittent communication due to inconsistent crimping of connectors onto cables.
If the venous cannula is used in an unintended manner (longer than 6 hours; particularly during extracorporeal membrane oxygenation [ECMO]) there is a risk that separation of the cannula…
Their is a possibility that the cannula may separate from its connector, potentially causing a breach of circuit during cardiopulmonary bypass which could result in significant blood loss.
The action has been initiated to address reports of burst balloons which have resulted in significant difficulty retrieving the device into the sheath and withdrawing the system from the…
The action has been initiated to address reports of burst balloons which have resulted in significant difficulty retrieving the device into the sheath and withdrawing the system from the…
The action has been initiated to address reports of burst balloons which have resulted in significant difficulty retrieving the device into the sheath and withdrawing the system from the…
The action has been initiated to address reports of burst balloons which have resulted in significant difficulty retrieving the device into the sheath and withdrawing the system from the…
Possibility of balloon rupture in intra-aortic occlusion devices. If the balloon bursts during cardiopulmonary bypass, the heart can fill and warm, the operative site may be obscured, and…
Potential for an electrical short circuit leading to possible fire hazard due to liquid ingress into AC power outlets.
Difficulty with atrioseptostomy catheter balloon deflation after deployment, and reports of balloon fragmentation or detachment.
Difficulty with atrioseptostomy catheter balloon deflation after deployment, and reports of balloon fragmentation or detachment.
Edwards Lifesciences has received a limited number of customer reports regarding an inter-lumen leak between the cardioplegia lumen and pressure lumen in the device.
This action has been initiated to address complaint reports received for crimp balloon and inflation balloon component separation during TAVR procedures.
These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If the lumens are reversed the clinician may note reverse PA and CVP pressure values and…
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.
