Natick firm in heart device advisory
SAN FRANCISCO — Boston Scientific Corp. advised doctors that a part in certain models of its implanted heart defibrillators made in 2006 and 2007 has a “somewhat higher’’ failure rate, requiring units to be reprogrammed.
About 34,000 patients still have the defibrillators implanted, though they are no longer sold, according to an advisory posted yesterday on the Natick, Mass., company’s website. The observed failure rate is one in 670 devices, and no deaths or injuries have been reported.
Boston Scientific temporarily recalled its defibrillators March 15 after failing to notify US regulators of manufacturing changes. In April, the company recorded $1.8 billion in costs from the monthlong withdrawal. Chief executive Raymond Elliott has said the recall will trim 4 percentage points this year from the company’s share of the US defibrillator market.
“Boston Scientific recommends that physicians continue routine follow-up sessions and reminds patients to contact their clinic or go to a hospital emergency room immediately if they hear beeping tones from their device,’’ the company said.
