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Boston Scientific, the Natick-based medical device manufacturer, has stopped shipments and is calling back inventories of two defibrillators after the company said it failed to report manufacturing process changes to the Food & Drug Administration.
The company said it has no reason to believe the manufacturing process changes pose any danger to patients. Stopping the shipments and recalling the inventories are voluntary steps, CEO Ray Elliott said in a statement.
The move impacts all of the company's implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators. It could have an impact on the company's first quarter and year-end financial results, the company also said.
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Worcester Business Journal presents a special commemorative edition celebrating the 300th anniversary of the city of Worcester. This landmark publication covers the city and region’s rich history of growth and innovation.
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