Arrow Recalls FiberOptix Intra-Aortic Catheter

Arrow International has recalled (Class 1) its Arrow FiberOptix Intra-Aortic Balloon Catheter Kit after receiving reports about “infrequent” device malfunctions that could result in serious health consequences. According to a recall notice, the issues may “manifest” as failure of the intra-aortic balloon to completely inflate over its full length; a damaged or broken central lumen in the segment contained within the balloon; and helium loss or blood in the helium pathway. FDA has identified the cause as “nonconforming material/component.”

Arrow sent an “urgent medical device notification” to users in April advising them on the actions to be taken to avoid device complications. For example, the company said that prior to insertion, users should inspect all in-scope catheters for signs of an over-twisted balloon wrap or bent balloon shaft. It also recommended to insert all catheters under fluoroscopic guidance.