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Arterial Cannula Recall: Edwards Lifesciences Removes Arterial Cannula due to Risk of Wire Exposure

Edwards LifeSciences is recalling arterial cannulae due to occurrences in which a 3mm to 4mm section of wire, from the wire-reinforcement coil at the cannula tip of the OptiSite Arterial Perfusion Cannula devices, was found to be exposed (released from the cannula body). Since some Femoral Arterial Cannula models are made of the same components as the impacted OptiSite Arterial Perfusion Cannula, Edwards has included those Femoral Arterial Cannula models as affected product to be removed from use.

This recall involves removing devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.

Questions?

Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact their Edwards eCV Representative or Edwards Customer Service at FCA_ECV@edwards.com or 888-943-2783.