Endologix recalled its AFX Introducer System back in May, and now the FDA has assigned its most serious warning to the catheter-insertion device, saying it could cause serious injury or death. The company launched the recall in response to reports that the device's dilator could break during implantation procedures, asking customers to cease using and distributing the product, and the FDA has designated the recall a Class I, used only when products put patients at serious risk. More