ReFlow Medical voluntarily recalled certain lots of its Wingman35 Crossing Catheters, which are used in the peripheral vasculature.
The company announced the recall May 3 after discovering the catheters exhibited tip splitting or separation, which resulted in two adverse events.
The FDA deemed the action a class 1 recall, which the agency defines as “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”
The recalled products were distributed between January 2015 and March 2016. ReFlow Medical said that 2,327 Wingman catheters are in distribution.
According to the company, tip splitting could lead to loss of device function and tip separation could require medical intervention or occlude blood flow to end organs.
In October 2014, the FDA granted a 510(k) clearance to the Wingman35 Crossing Catheters, which are used with steerable guidewires to access discrete regions of the peripheral vasculature and enable lesion crossing.