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St. Jude Heart Devices With Battery Defects Lead to Recalls

 
St. Jude Medical has recalled some of its implanted heart devices due to the risk of premature battery depletion, a condition linked to two deaths in Europe.

The device maker, in a letter to doctors, said potential battery depletion could occur among an estimated 398,740 company implantable cardioverter defibrillators (ICDs) worldwide—devices used to shock a dangerously racing heartbeat back to its normal rhythm. All contain batteries that were manufactured before May 23, 2015, when the company added insulation to reduce the chance of an electrical short circuit.

St. Jude said 841 devices had been returned to the company for analysis due to premature battery depletion, traced to a build-up of lithium clusters in the batteries. Depletion of power can quickly render the devices unable to deliver doses of electricity when needed.

The devices were introduced in 2010 and are meant to last for 7 years or longer, until their batteries are depleted, the company said. They are designed to vibrate at regular intervals once power is diminished, a signal to patients that they should visit their doctors for replacements within 90 days.

Problems with the lithium batteries could be identified by patients using tools for monitoring battery levels at home.

Patients should seek immediate medical attention as soon as they get a low-battery alert from the monitoring devices, the U.S. Food and Drug Administration said, in announcing the recall.