Boston Scientific said two models of its cardiac defibrillators have been malfunctioning, but at a very low rate. One patient has died.
The company told the U.S. Food and Drug Administration that it has been seeing malfunctions in Cognis and Teligen defibrillators, which are implanted in 233,000 people worldwide. The devices use an electric shock to prompt a stopped or erratically beating heart back into a normal rhythm.
The company said 26 of the units have malfunctioned, or about one in 8,900. Though one patient has died, the company said the devices are performing within Boston Scientific's expectations of reliability.
The devices have not been recalled and Boston Scientific is providing doctors and patients with additional information. The company said an independent panel of physicians and safety advocates reviews malfunctions. Bloomberg News Service said the problem involves a component that can overheat. Boston Scientific is rolling out a new generation of defibrillators without that component.