A medical device manufacturer has issued an urgent recall to correct several types of heart devices after the Food and Drug Administration (FDA) classified the action as its most serious type of recall, the agency said in a notice on Thursday.
The recall does not require the devices to be removed from patients’ bodies or from where they are sold, according to the notice. Doctors are being told by the recalling company, Boston Scientific, that they need to update the devices’ software during an in-person visit.
