Device manufacturer Guidant Corp. is warning doctors of two separate failure modes in the Insignia and Nexus families of its implantable pacemakers. The Food and Drug Administration may classify the warning as a recall, Guidant said.
The failures can result in serious health complications, but they are each occurring at a low rate and there have been no reported deaths resulting from them, the company said. Guidant has confirmed that as of Sept. 6 there were 36 failures out of 49,500 implanted devices in the first failure mode and 16 failures out of 341,000 devices distributed worldwide for the second failure mode.
Guidant recommended that physicians verify pacemaker operation in the packaging before implanting them.