Boston Scientific Corporation (NYSE:BSX)’s Lotus transcatheter is being recalled due to a fault in the deployment of the system. The fault was attributed to a deployment tool’s pin that risked disconnecting prior to a doctor releasing the device. A spokesperson for the company said that a patient died following a failed attempt at implanting another valve after the previous one also failed.
“All affected patients were successfully treated with another valve, except for one reported case where implantation of the second valve was associated with aortic dissection and subsequent death,” Trish Backes, a spokesperson for the company said in an email.
Global recall
In the announcement which Boston Scientific was made to investors, hospitals all over the world were requested to send back any Lotus transcatheter that were yet to be implanted.
Though the Lotus transcatheter has received European approval it is still undergoing trials in the United States. With the device planned for a mid-2018 launch in the United States, Boston Scientific plans to have applied to the Food and Drug Administration for the commercial approval of the device. Management of the device is under Boston Scientific’s heart division which is located in the Maple Grove area.
This is not the first time that the Lotus range of devices are experiencing problems as there was a suspension of Lotus Edge implants last year in Europe because of similar challenges. The company, however, found a solution to the problem last month.
Set for a comeback
Despite the setback, the company said that the devices are set for a European market return in quarter four of this year. The market in which the Lotus transcatheter was serving is expected to reach a figure of $5 billion in five years as it grows by an annual rate of between 10% and 15%.
Analysts expect that the recall will lead to a drop in revenue totaling $50 million in 2017 and approximately $60 million in 2018. To rebuild and restore credibility, Boston Scientific will be adding an extra inspection step.
In Thursday’s trading session, shares of Boston Scientific Corporation fell by 2.7% to close the day at $24.48.
