www.fdanews.com/articles/179019-st-jude-medical-recalls-cardiac-defibrillators
St. Jude Medical Recalls Cardiac Defibrillators
October 25, 2016
St. Jude Medical has issued a recall on certain models of the Fortify, Unify, and Assura Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) due to reports of rapid battery failure caused by deposits of lithium (known as “lithium clusters”), forming within the battery, and causing a short circuit.
St. Jude Medical Implantable ICDs and CRT-Ds are devices that provide pacing for slow heart rhythms, and electrical shock or pacing to stop dangerously fast heart rhythms. The FDA has declared the action a Class I recall.