Pacemakers implanted medical devices that are used to electrically stimulate the heart. They are used in patients suffering from heart rate abnormalities. Pacemakers help to pump blood throughout the body. The devices contain small electronic circuits along with a battery. The pacemaker is attached to the heart with long wires that go through veins directly into the heart.
On July 18, 2005 Guidant Corporation announced a voluntary recall of their heart pacemakers. The reason being that the devices needed to be replaced due to faulty sealing components. At that time nine different pacemaker models manufactured by Guidant were recalled.
Prior to the recall there had been 69 reports of patient problems resulting from pacemaker malfunctions. These included both acceleration and deceleration of the pace which resulted in some cases of patients losing consciousness or heart failure.
As the FDA is making no recommendations about replacement of the pacemakers, rather they have left it up to the doctors as to whether replacement should be an option.