FDA: Class I recall of Wingman35 Crossing Catheters

Editor's Note

The Food and Drug Administration on May 17 identified the recall by ReFlow Medical (San Clemente, California) of certain lots of its Wingman35 Crossing Catheters as Class I, the most serious.

The catheters are being recalled because of tip splitting or separation that has resulted in two adverse events. If a catheter tip splits or separates during a case, it can enter the patient’s blood stream and result in injury to blood vessel walls, development of blood clots, embolism, heart attack, or death.

The catheter is used with steerable guidewires to assist with the placement and exchange of interventional devices and administer drugs or fluids.

The catheters were distributed between March 1, 2015 and March 17, 2017.

Tip splitting has the potential to lead to loss of device function. Tip separation may require medical intervention to retrieve a separated segment or may occlude blood flow to end organs.