FDA Class I Recall of Wingman35 Crossing Catheters

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Washington, DC: A Class I recall of defective catheters has been issued for lot-specific Wingman35 Crossing Catheters by the US Food and Drug Administration (FDA) and ReFlow Medical.

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.

The Wingman35 Crossing Catheters have been found to exhibit tip splitting or separation, which has resulted in two adverse events.

ReFlow has received 2 complaints of catheter-tip splitting and/or separation. Tip splitting has the potential to lead to loss of device function. Tip separation may require medical intervention to retrieve a separated segment or may occlude blood flow to end organs.

A total of 2327 Wingman catheters are in distribution.The Wingman Crossing Catheters in this recall were distributed between January 2015 and March 2016.



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