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Click Here to Find Out If Your Pacemaker Has Been Recalled.

       On June 17, 2005, Guidant announced the initiation of a voluntary recall of certain pacemakers.  It has been discovered that a seal within the device can leak, allowing moisture to damage electronic components.  Such damage can affect the device’s ability to pace the heart or can cause an accelerated heart rate. Guidant sent a letter to physicians describing the problems and providing recommendations about how to decrease the risk of pacemaker failure.

       Guidant’s recall has been categorized as a Class 1 recall, the FDA’s most serious designation.  This means there is a reasonable probability that the malfunctioning device will cause serious adverse health consequences or death.  Given that many patients are very dependent on such pacemakers to maintain an adequate heart rate, this news is significant for the nearly 30,000 people worldwide who have the affected devices installed.

       The clinical behaviors related to a malfunctioning device can be serious.  In some cases, patients have experienced syncope, more commonly referred to as “fainting” or “passing out.”  On two occasions, patients sustained Maximum Sensor Rate (“MSR”) pacing in which heart failure may have developed due to the sustained high rate pacing.  In one instance, a patient was admitted to the hospital after experiencing sustained MSR along with multiple other health issues and later died.

       Guidant has recommended to physicians that they consider each case on an individual basis when evaluating what measures to take with regard to a defective device.  Additionally, patients have been advised to immediately seek medical attention if they notice shortness of breath, dizziness, lightheadedness or a prolonged fast heart rate.

       If you have been injured as a result of a defective Guidant Pacemaker, you may be entitled to monetary compensation.  For a free review of your claim, please complete a free consultation form.  A lawyer will review your form and may contact you to discuss your case.

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