The United States Food and Drug Administration (FDA) has issued a medical device safety alert concerning Wingman35 Crossing Catheters, manufactured by ReFlow Medical Inc.
The manufacturer initiated a lot-specific voluntary recall of 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 Wingman Crossing Catheters in this recall were distributed between January 2015 and March 2016.
The manufacturer has notified its customers and distributors by recall notification letters. The letters requested that all customers and distributors quarantine and discontinue use of all potentially affected units and return the affected product to the company as soon as possible for credit.
For details, please refer to the FDA websites:
https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm556541.htm
https://www.fda.gov/Safety/Recalls/ucm556525.htm
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 4 May 2017