The FDA today released information on a select recall of ReFlow Medical Wingman35 crossing catheters over issues with device tip splitting or separation, labeling it as Class I.
Class I recall designations, the agency’s most serious classification of recall, are used when there is a reasonable probability that product use could cause serious adverse health consequences or death.
The recall is over issues with tip splitting and separating during use, which has the potential to lead to loss of device function, and could require medical intervention to retrieve separated segments. Segments could occlude blood flow to end organs and could result in serious injuries or death.
ReFlow Medical issued its own lot-specific voluntary recall of the catheters on April 22, according to the FDA release. A total of 2,327 units are affected by the recall, distributed between Jan. 2015 and March 2016.
ReFlow Medical has received 2 complaints of tip splitting or separation, according to the release. The company notified customers and distributors and instructed them to quarantine and discontinue use of all affected units and return them as soon as possible for credit.