FDAnews Device Daily Bulletin

St. Jude Medical Recalls Cardiac Defibrillators

Oct. 26, 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.

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