Thomas Medical Recalls Coronary Sheaths

Thomas Medical Products is conducting a Class I recall of SafeSheath CSG coronary sinus guide hemostatic introducer systems with an infusion sideport, the FDA says. The sheath tip can break off while the sheath is inside a blood vessel, move through the vessel into organs or arteries, and cause a blockage that could lead to permanent injury or death, according to the agency. The affected sheaths were made and distributed from Dec. 1, 2005, to Dec. 1, 2009.