More defibrillators, pacemakers recalled

It seems that just when it seems that the recall problems are over, another device is identified. In fact, in this month alone, two recalls were issued for heart devices.

The most recent recall is by Boston Scientific Corp. Again, a problem exists with the electrical system in the devices. Now another 27,000 devices are considered at risk.

Boston Scientific spokesman Paul Donovan said "we're recommending that people see their doctors at the earliest opportunity."

The devices causing the scare 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. In four cases, patients required surgery to replace devices. In another, the malfunction was discovered when the device was being implanted.

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.