Device Recall Edwards Lifesciences Duraflo coated FemFlex II Femoral Arterial Cannula

Model DIIFEMII018A, Lot 59337174

Cardiovascular Devices

2

No

USA Nationwide Distribution including the states of: FL, MA, MI, NY, PA, TX.

Edwards Lifesciences Duraflo coated Femoral Cannula. || Product Usage: || The cannulae are intended for use in situations which require rapid femoral venous and arterial access for short-term (< 6 hours) cardiopulmonary bypass. Vessel access (venous or arterial) is left to the discretion of the physician. Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin-coated blood path is desired. || The femoral arterial cannulae are wire-reinforced, thin-wall cannulae.