FDA flags problems with two Boston Scientific heart devices tied to injuries and deaths
By MATTHEW PERRONE
WASHINGTON (AP) — U.S. health regulators are warning doctors and patients about safety issues with two separate Boston Scientific heart devices recently linked to injuries and deaths.
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The Food and Drug Administration issued two alerts Wednesday about electrical problems tied to the company’s heart-zapping defibrillator systems and a separate issue with a heart implant used to reduce stroke risk.
The agency said some of the company’s Endotak Reliance defibrillator wires can become calcified, leading to failures in delivering life-saving shocks to the heart, according to the FDA.