www.fdanews.com/articles/177786-boston-scientific-recalls-select-valves-due-to-release-mandrel-breakage
Boston Scientific Recalls Select Valves Due to Release Mandrel Breakage
August 2, 2016
Boston Scientific has issued a recall for Lotus valve devices with issues with release mandrel breakage.
The release mandrel is a delivery system component connected to the release pin.
The company said it has received numerous reports of catastrophic vessel trauma associated with damaged versions, including three reported patient deaths. — Cynthia Jessup