Analysts say that Boston Scientific may have been hasty in stopping sales of its implantable heart rhythm devices. According to Reuters, the company pulled its implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy devices after realizing that it had failed to submit documents to FDA for changes that it had made to its manufacturing processes. When halting sales, Boston Sci said that the devices didn't pose any risk to patients.
Boston Sci says it is working with FDA to resolve the issue, according to Reuters. It generally takes 30 days for FDA to review manufacturing process changes. The device maker's shares dropped about 20% after announcing that it had stopped sales.


