More defibrillators, pacemakers recalled

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.

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