Boston Scientific (NYSE:BSX) announced today that it has initiated a global, voluntary recall of its Lotus Edge aortic valve system — and is immediately retiring the Lotus program.
Marlborough, Mass.-based Boston Scientific said in a news release that the recall of all unused inventory of its Lotus Edge transcatheter aortic valve repair (TAVR) system is due to complexities related to the product delivery system and solely that — as the valve has achieved positive and clinically effective performance post-implant.
Patients currently implanted with Lotus Edge do not have any safety issues to be concerned about, according to the company.
