This recall is being conducted with the knowledge of the U.S.
REFLOW MEDICAL DOWNLOAD
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ReFlow has received 2 complaints of catheter-tip splitting and/or separation. The Wingman35 Crossing Catheters have been found to exhibit tip splitting or separation, which has resulted in two adverse events. 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.
On April 22, 2017, ReFlow Medical initiated a lot-specific voluntary recall of the Wingman35 Crossing Catheters.