Medical Device Safety and Recalls: ReFlow Recalls Wingman 35 Crossing Catheters due to Tip Separation

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Medical Device Safety and Recalls: ReFlow Recalls Wingman 35 Crossing Catheters due to Tip Separation

Reflow is recalling the Wingman 35 Crossing Catheter due to a risk of the catheter tip splitting or separating. If a catheter tip splits or separates during use, it can enter the patient's bloodstream and can result in serious adverse health consequences such as injury to blood vessel walls, development of blood clots, embolism, heart attack or death.

On March 22, 2017, ReFlow Medical issued a recall notice for lots 1602164 and 1602164R. As of April 19, 2017 ReFlow Medical determined additional lots could be affected, so the recall has been expanded.

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