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Guidant Pacemaker Recall List

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Several patients implanted with its pacemakers have lost consciousness or developed possible heart failure, Guidant said, and one patient may have died due to a faulty pacemaker.

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.

Boston Scientific spokesman Paul Donovan said a letter the company sent to doctors did not recommend surgeries to remove potentially faulty devices.

"Instead, we're recommending that people see their doctors at the earliest opportunity," Donovan said.

The company was advising doctors to check for signs of a malfunctioning capacitor, such as prematurely dead batteries or a device that stops working as intended to restore a normal heart rhythm.

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 had been criticized for failing to notify doctors, patients and regulators of the extent of its product problems, and Boston Scientific has vowed to do a better job.

On July 18, 2005 , the Guidant Corporation warned physicians that replacements might be needed for nine pacemaker models made between 1997 and 2000, of which some 28,000 remain implanted in patients worldwide.

The Guidant Corporation issued its fourth recall of implanted heart devices since late May 2005, saying the hermetic seal on older versions of nine pacemakers can gradually degrade, causing the devices to fail.

Guidant's warning states that a sealing component in the pacemakers has degraded in some cases, resulting in higher-than-normal moisture in the devices and possible malfunction. Guidant has identified 69 pacemakers with the problem of about 78,000 originally implanted.

Guidant Pacemaker Recall List

Guidant has confirmed twenty reports of loss of pacing output associated with this failure, including five patients experiencing syncope. Loss of pacing output has also been associated with reports of presyncope requiring hospitalization. Guidant has received two reports of sustained Maximum Sensor Rate ("MSR") pacing in which heart failure may have developed in association with sustained high rate pacing.

According to Guidant, physicians should consider replacing the devices for patients who are dependent on the devices. Patients should seek medical attention immediately if they notice shortness of breath, dizziness, lightheadedness or a prolonged fast heart rate.

In July 2005, Guidant recalled almost 109,000 heart defibrillators. Defibrillators, three times the size of pacemakers, are also implanted; they shock the heart back into rhythm when it beats too quickly.

The recall applies to a subset of the following pacemaker models: the Pulsar Max, Pulsar, Discovery, Meridian , Pulsar Max II, Discovery II, Virtus Plus II, Intelis II and Contak TR.

The affected devices were implanted between Nov. 25, 1997 and Oct. 26, 2000 . As the seal degrades, the pacemaker is exposed to higher-than-normal moisture levels.

First Recall Replacement, June 17 2005

Manufactured on or before August 26, 2004.

First Recall Reprogramming June 17, 2005

Second Recall Replacement; June 23, 2005

All serial numbers of CONTAK RENEWAL 3 and 4 , RENEWAL 3 and 4 AVT , and RENEWAL RF .

Third Recall Replacement; July 18, 2005

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