Wingman35 Crossing Catheters Recalled Due to Tip Splitting, Separation

Device manufacturer ReFlow Medical says the issue has resulted in two adverse events, which did not involve patients.

A recall of certain lots of Wingman35 Crossing Catheters (ReFlow Medical) used in peripheral interventions has been deemed a Class I action, the most serious type, by the US Food and Drug Administration.

The action, which was initiated on April 22, 2017, and affects devices distributed between January 2015 and March 2016, is due to reports of splitting or separation of the catheter tips, resulting in two adverse events. In an email to TCTMD, ReFlow Medical said that in both cases, the problems were discovered before the devices were used in patients.

The company sent customers and distributors recall notification letters telling them to quarantine all potentially affected devices and return them for credit.

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