Medical Device Safety Alert: Edwards Lifesciences Femoral Arterial and Venous Cannula

Edwards Lifesciences has identified an increase in the use of our Femoral Arterial and Venous Cannula in adult and pediatric populations in a manner that is not intended resulting in leaks. Some of the reported events resulted in death and others in significant blood loss. The information received is from cases where the product was in use during an Extracorporeal Membrane Oxygenation (ECMO) procedure. Additionally, some of the reported events involved device placement outside of the indicated femoral locations resulting in dislodgement of the product and significant blood loss.

As a result Edwards is adding contraindications to the instruction for use included with the device models listed below.

Femoral Access cannulae are contraindicated for long-term use (> 6 hrs), including Extra Corporeal Membrane Oxygenation (ECMO) procedures.

Devices are contraindicated for placement in vasculature outside of the femoral artery or vein.

The products listed below are included in this field action. The current shelf life of these products is three years.