St. Jude Medical announced today that as many as 400,000 of its Fortify, Fortify Assura, Quadra Assura, Unify, Unify Assura and Unify Quadra implantable cardiac defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices manufactured prior to May 23, 2015 are subject to a recall notice due to a risk of premature battery depletion which may render the device unable to deliver a life saving shock.
According to the FDA, the patients most at risk are those who require lifesaving shocks and those who are pacemaker dependent.
The problem has so far resulted in two deaths.
Patients with these devices should contact their physicians for advice about how to proceed, and should seek immediate medical attention if they hear a low-battery alert from their Merlin monitoring device.
St. Jude advised patients to check its website for details on which devices were affected by the battery issue. ***This website has a search function where you can search with your model number and serial number and find out if you are personally affected.
The FDA Alert can be found here.
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