The FDA is classifying this as a Class 1 recall, the most serious recall situation where the patient is exposed to a reasonable likelihood of death or a serious injury.
The Wingman35 Crossing Catheters have been found to exhibit tip splitting or separation, which has resulted in two adverse events.
ReFlow has received 2 complaints of catheter-tip splitting and/or separation. 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.
A total of 2327 Wingman catheters are in distribution.The Wingman Crossing Catheters in this recall were distributed between January 2015 and March 2016.