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Tip separation may require medical intervention to retrieve a separated segment or may occlude blood flow to end organs. View ReFlow Medical (location in California, United States, revenue, industry and description. Tip splitting has the potential to lead to loss of device function. A total of 2327 Wingman catheters are in distribution. 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.
#REFLOW MEDICAL SERIES#
The companys devices have a series of radially expandable spikes that. 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. Developer of medical devices designed to treat peripheral cardiovascular diseases. On April 22, 2017, ReFlow Medical initiated a lot-specific voluntary recall of the Wingman35 Crossing Catheters.