According to Reuters, Boston Scientific is recalling all ranges of its transcatheter aortic valve implantation (TAVI) device Lotus. The news agency reports that the recall relates to a locking mechanism problem and has sent the company’s shares down by “as much as 7.4%”. Boston Scientific has also apparently delayed submitting the US marketing application for its Lotus Edge device.
Reuters state that Boston Scientific’s Lotus devices are expected to return to the European market and other regions in the fourth quarter. They add that Boston Scientific says that the issue with the valves was caused by excess tension in the pin mechanism that was introduced during manufacturing.
The company suspended implants of Lotus Edge device in Europe last year, but claimed to have found a solution to the issue last month. Reuters also note that while the company previously expected to submit US marketing application for the Lotus Edge device in May and get an approval by the end of 2017, it now has pushed the submission of the application to the fourth quarter and expects to launch it in mid-2018.
