Boston Scientific Voluntarily Recalls All Lotus TAVR Devices


February 23, 2017—In a Form 8-K report to the US Securities and Exchange Commission (SEC), Boston Scientific announced a voluntary removal of all Lotus transcatheter aortic valve replacement (TAVR) devices, including Lotus with Depth Guard, from global commercial and clinical sites.

According to Boston Scientific, the action is a response to reports of the premature release of a pin connecting the Lotus valve to the delivery system. As with the previously announced suspension of the Lotus Edge valve system device, it is believed that the issue is caused by excess tension in the pin mechanism introduced during the manufacturing process, advised the company.

Boston Scientific stated in the SEC filing that the company expects to bring the Lotus TAVR platform back to market in Europe and other regions in the fourth quarter of 2017. In addition, the company anticipates filing the premarket approval submission with the US Food and Drug Administration for the Lotus Edge valve system, the next-generation platform, in the fourth quarter of 2017, with a United States launch planned for mid-2018. 


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Cardiac Interventions Today (ISSN 2572-5955 print and ISSN 2572-5963 online) is a publication dedicated to providing comprehensive coverage of the latest developments in technology, techniques, clinical studies, and regulatory and reimbursement issues in the field of coronary and cardiac interventions. Cardiac Interventions Today premiered in March 2007 and each edition contains a variety of topics in a flexible format, including articles covering various perspectives on current clinical topics, in-depth interviews with expert physicians, overviews of available technologies, industry news, and insights into the issues affecting today's interventional cardiology practices.