Boston Scientific recalls certain lots of its Lotus Valve System

Boston Scientific voluntarily recalled certain lots of its Lotus Valve System that were manufactured before March 2016.

The Lotus Valve System, used in transcather aortic valve replacements, is not yet FDA-approved.

The company sent a letter to hospitals and customers explaining that the recall was due to breaks in the release mandrel, a component of the delivery system. Mass Device first reported on the recall.

The release mandrel breaks led to three patients dying of catastrophic vessel trauma, according to Boston Scientific.

Since the company made a component change in March, it said it had not received reports of release mandrel breaks.