Marlborough medical device manufacturer Boston Scientific has voluntarily recalled the unused inventory of one of its aortic valve systems and announced it will discontinue the product.
In a press release sent out Tuesday, the medical device manufacturer announced it was issuing a voluntary recall of unused LOTUS Edge Aortic Valve System due to “complexities associated with the product delivery system and would be ceasing production of the entire system all together.
The news was met with an immediate drop of over 10% in the company’s stock on the New York Stock Exchange, which is still down over 10%, at $34.06 a share as of 1:20 p.m., from its level ahead of the announcement.
According to the company, this recall is only being made due to the delivery system as the valve continues to be effective and there are no safety issues for patients who have one of the valves implanted. The time and investment required for an enhanced delivery system lead the company to the retirement of the entire LOTUS product platform.Â
“We have been increasingly challenged by the intricacies of the delivery system required to allow physicians to fully reposition and recapture the valve,” said Mike Mahoney, chairman and CEO of Boston Scientific in the release.Â
Everything related to the valve system from research to production will cease immediately.
The company will instead focus on other products and valve systems, according to Mahoney.
The decision is expected to cost the company between $325 and $450 million once the cost of existing inventory and other associated charges is taken into account.
