Getinge/Maquet Recalls VasoView HemoPro 2 Devices

Getinge and its subsidiary Maquet Cardiovascular are recalling (Class 1 instructions for use update) the VasoView HemoPro 2 (VH-4000 and VH-4001) Endoscopic Vessel Harvesting Systems due to the possibility of two failure modes being experienced during use. A recall notice describes the failures as a bent or detached heater wire, and silicone peeling or detaching from the jaws of the harvesting tool. “The use of affected product may cause serious adverse health consequences, including bleeding, burns, injury, or blockage (embolism or occlusion) of blood vessels, infection, and death,” the notice says. To date, there have been seven reported serious injuries, four for the heater wire and three for silicone peeling or detaching. The devices are used in patients undergoing endoscopic surgery to create a new path for blood flow in the arteries (arterial bypass), FDA says.