04/17 St. Jude Medical Played Down Defibrillator Failures for Years, F.D.A. Says
The medical device maker St. Jude Medical played down the failure of some batteries in its defibrillators, shipping them for years before recalling the devices last fall, according to a warning letter the Food and Drug Administration issued this week. The company, acquired by Abbott Laboratories in January, also failed to tell its own management and a medical advisory board that the battery problems had led to the death of a patient, the agency found. The F.D.A. said St. Jude Medical had not shown it was taking sufficient action to fix the problems that led to the slow […]