They've received their second warning letter from the FDA this month. The latest concerns two people in shipping who shipped equipment that had failed quality tests and been placed in quarantine. They overrode a computer system designed to prevent this from happening.
Now, it's not as though the company makes simple, non-critical medical devices. They make stents, the devices that are inserted in arteries. Nor is Boston Scientific new to the world of medical devices. They've been making them for twenty-five years and sold more than $5 billion last year.
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