A week ago, Guidant Corp. announced that it was voluntarily recalling several models of its cardiac defibrillators, which were implanted in about 50,000 people around the world.
Now Guidant has advised doctors against implanting later, more sophisticated versions of their defibrillators. The company says that these models may be flawed as well, and may also be recalled.
The models announced to be questionable last week were linked to the deaths of two people, and were reported to malfunction in 45 different cases. Reuters reports:
Guidant said it is advising doctors about safety problems with its Contak Renewal 3 and 4, Renewal 3 and 4 AVT, and Renewal RF implantable cardioverter defibrillators, or ICDs.
Guidant said it has determined that a magnetic switch in these devices may get stuck in the closed position, which in some cases inhibits their ability to treat ventricular or atrial tachyarrhythmias and can accelerate battery depletion.
The other models that were recalled last week included:
“Patient safety is paramount and our highest priority,” Guidant President and CEO Ronald W. Dollens said last week. “As a leading manufacturer of lifesaving technology, Guidant takes seriously its responsibility to create the most reliable products and services, enhance patient outcomes and limit adverse events to patients.”
Guidant may run into trouble with its deal to be acquired by Johnson & Johnson. According to Reuters, Shares of Guidant went down 12% in early trading today.
Chris is a staff writer for Murdok. Visit Murdok for the latest ebusiness news.