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Cardiac Crossing Catheters Recall; Tip Splitting, Separation


On May 3, 2017, ReFlow Medical recalled the Wingman35 Crossing Catheters. The Wingman35 Crossing Catheters have been found to exhibit tip splitting or separation, which has resulted in two adverse events.

 

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.

 

The products affected by this recall were distributed between January 2015 and March 2016. A total of 2,327 Wingman catheters are in distribution.

 

The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.

 

See the FDA Safety Alert

 

See the Recall

 

 

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