FDAnews Device Daily Bulletin
Medical Devices / Postmarket Safety

Boston Scientific Recalls Select Valves Due to Release Mandrel Breakage

Aug. 3, 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

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