Boston Scientific to voluntarily recall LOTUS Edge aortic valve system due to snag with delivery system

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Boston Scientific Corp. said Tuesday it has launched a voluntary recall of unused stock of its LOTUS Edge Aortic Valve System due to “complexities” relating to the product delivery system. “The voluntary recall is related solely to the delivery system, as the valve continues to achieve positive and clinically effective performance post-implant,’ the company said in a statement. There are no safety concerns for patients who currently have an implanted valve, it said, but Boston Scientific has opted to retire the product given the long time and investment needed to improve the delivery system. The company is expecting to book pretax charges of $225 million to $300 million to cover the cost of the recall and about $100 million to $150 million will impact adjusted earnings. The company is expecting to book most of the charges in the fourth quarter, a decision expected to boost 2021 earnings by 1 to 2 cents a share and to be neutral after that. Shares fell 2% premarket and are down 16% in the year to date, while the S&P 500 has gained 12%.
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