FDA today designated a Medtronic recall of Rashkind balloon septostomy catheters as Class I, its most serious level.
The balloon catheters create an atrial septal defect or to enlarge an existing atrial septal defect in order to treat congenital heart defects.
Medtronic (NYSE:MDT) initiated a recall of the Rashkind balloon septostomy catheters in late August after learning of potential device quality issues that could lead to the device breaking, separating or failing during use. There have been two reported injuries and one death, according to FDA.
The recalled catheters come in 4, 5 and 6 Fr sizes. Overall, there are roughly 3,500 in circulation.
Medtronic has stopped making and distributing the Rashkind balloon septostomy catheters for reasons unrelated to the recall, according to FDA.