Did You Know?

Guidant Corporation made 3.8 billion dollars in 2004, 1.9 billion of that came from its successful and widely distributed Implantable Cardiac Defibrillators and Cardiac Resynchronization Therapy Devices.

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More defibrillators, pacemakers recalled

June 26, 2006 -

Boston Scientific Corp. on Monday said it is recalling more defibrillator and pacemaker models that could fail because of an electrical flaw.

The recall is the latest in a string of product problems Boston Scientific inherited when it bought Guidant Corp. in April for $27 billion.

Boston Scientific said it was asking its sales force and managers of hospital inventories to return some units of six models of defibrillators and pacemakers that have potentially faulty low-voltage capacitors, which are used to store electrical charges.

Boston Scientific Corp did not specify how many units were being returned, saying the recall involved a "subset" of certain models of devices that are designed to maintain a steady heart rhythm. About 27,000 devices that could have the problem had already been surgically implanted in patients.

The affected devices all were manufactured by Indianapolis-based Guidant, which Boston Scientific acquired April 21. Devices affected include Insignia and Nexus brand pacemakers, Contak Renewal TR/TR2 cardiac resynchronization pacemakers, and Ventak Prizm 2, Vitality, and Vitality 2 cardioverter defibrillators.

Of the 27,000 implanted devices that may have the flaw, problems have turned up in five patients, Boston Scientific said. None involved deaths, but in two cases pacemaker patients temporarily became unconscious.

Since June 2005, Guidant has issued safety warnings or recalled more than 88,000 defibrillators, and has recalled or issued warnings on about 200,000 pacemakers. Boston Scientific also inherited liability lawsuits connected with the products, which have been linked to at least seven deaths.

Guidant Recall - Quick Facts

Indianapolis-based Guidant has recalled 136,950 Guidant Defibrillators and Pacemakers. The company said about 63,000 of the devices had been implanted, with nearly 50,000 still in use. Guidant stated that the devices could, without warning, develop a short circuit that would prevent them from delivering the shock when needed. There have been reports of at least 45 malfunctions and are thought to have caused several deaths.

Guidant Pacemakers send electrical pulses to the heart to accelerate a slow heart beat, and have a seven- to 10-year life span before they must be replaced.

Guidant Defibrillators are small devices implanted into the body to regulate the heartbeat in people with risk of heart problems.

The exact percentage of these defibrillators that might experience a malfunction isn't known at this time.
Common signs of pacemaker failure include shortness of breath, dizziness, lightheadedness or a prolonged fast heart rate.

There were approximately 45 malfunctions and two deaths associated with this short circuit.

Without proper circulation patients may experience irregular heartbeats, fainting, dizziness, and shortness of breath.

Patients should understand that an FDA recall does not necessarily mean that the device will be removed from the market or that the device needs to be removed from the patient. Recall actions can also include correcting or modifying the device.

It is important for each patient to contact his or her doctor to discuss the best course of action, including whether or not to replace the device. This decision will depend on many factors, including the patient's condition and medical history.

Replacing the device may be advisable in some cases, but in other cases the risks associated with replacing the device, including the chance of infection or injury during replacement surgery, may be higher than the risk that the device will malfunction.

Guidant Corporation, which has a $25.4 billion acquisition offer pending from New Brunswick, N.J.-based Johnson & Johnson.
Since Guidant was incorporated in 1994, they have sold more than 50,000 ICDs. Quality began to suffer in 2002, when Guidant discovered that the insulation on some of the wiring in three models of ICD could accidentally short out and prevent the unit from functioning properly. Instead of halting production and recalling the units, Guidant decided to continue to sell faulty devices and address the malfunction in later models.

CONTACT A GUIDANT LAWYER IN BOSTON

If you or your loved one uses Guidant brand defibrillators or pacemakers, you could be in serious danger. Consult your doctor immediately, but then contact our lawyers right away.

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