Boston Scientific Corp. (NYSE:BSX) is warning physicians that some models of its implantable cardiac defibrillators have shown a higher rate of magnetic reed-switch failure, according to the Wall Street Journal.
The Natick, Mass.-based medical device maker said the ICDs, manufactured between January 2006 and November 2007, aren’t distributed today. No patient deaths or injuries beyond device replacement have been reported, according to the Journal, which noted that Boston Scientific attributed a rate of one failure per 670 devices to the problem. The probability of harm is estimated to be less than one in one million.
It’s another bit of bad news for Boston Scientific’s embattled cardiac rhythm management division, which is still reeling from a month-long shutdown earlier this year.
Reporting its second-quarter results July 20, BSX said defibrillator sales fell 17 percent in the second quarter. Profits slid 38 percent for the quarter on double-digit declines of defibrillator and stent sales.
In the advisory letter (PDF), Boston Scientific said the application of a magnet may cause the magnetic reed switches in the device to permanently lock in the closed position, according to the Journal (paid). The company is recommending that patients continue with routine follow-up sessions, rather than replacing the devices, the newspaper reported.
