Boston Scientific issues urgent heart device software recall
Boston Scientific is recalling heart device software after four deaths and thousands of injuries. Doctors must now update the devices during clinic visits.
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BOSTON SCIENTIFIC CORP issued an urgent recall for heart devices linked to four deaths and 2,557 injuries after the United States Food and Drug Administration classified the action as its most serious recall. The FDA designated the software-based correction as a Class I recall on late evening May 7. The non-invasive software fix avoids surgical risks associated with physical device replacement.
