MARLBOROUGH, MA — Boston Scientific is recalling all of its Lotus heart valves from commercial and clinical sites around the world "due to reports of premature release of a pin connecting the Lotus Valve to the delivery system," the company reported to the US Securities and Exchange Commission today[1].
The problem is apparently caused by "excess tension in the pin mechanism introduced during the manufacturing process," it said. The issue involving the device's release mechanism is reminiscent of those that led to Lotus recalls in both 2016 and 2014. Last year the company said the problems, which involved the valve delivery system, didn't represent a safety issue for patients already implanted with the valves.
"We expect to bring the Lotus Valve platform back to market in Europe and other regions in the fourth quarter of 2017," Boston Scientific said, adding it expects to submit premarket approval application for the Lotus Edge Valve System, approved in Europe, with the US Food and Drug Administration in the fourth quarter of this year.
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Cite this: Boston Scientific Recalls All Lotus Heart Valves - Medscape - Feb 23, 2017.
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