Class 1 Recall: ReFlow Recalls Wingman 35 Crossing Catheters due to Tip Separation
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
The Wingman 35 Crossing Catheter is used with steerable guidewires to access veins and arteries not in the chest or abdomen. It may be used to assist with the placement and exchange of guidewires and other interventional devices and administer drugs or fluids into blood vessels.
Reason for Recall
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.
Who May be Affected
What to Do
On April 20, 2017, ReFlow Medical sent an Urgent: Medical Device Recall letter to all affected customers. The letter asked customers to:
Customers may contact ReFlow Medical Customer Relations at 1-949-481-0399, Monday through Friday, between 8:00 a.m. and 4:30 p.m. Pacific time or by email at firstname.lastname@example.org with any questions related to this recall.
Date Recall Initiated
March 22, 2017