Guidant Corporation has provided the FDA with reports about several recent patient deaths connected to recalled Guidant heart devices. The new reports raise the number of deaths from those devices to seven. According to agency records, those deaths resulted from short circuits in the devices, and they occurred after Guidant issued a recall of several devices in June 2005. The electrical failures in several models of Guidant devices involve an insulating material called polymide.
The recalled Guidant devices include defibrillator models, as well as pacemaker models. Due to the recall, doctors and family members may be more likely to have a heart device checked after a patient dies.
The recalls came after the New York Times reported that for three years, Guidant failed to tell doctors and patients about known defects in some device models. The Justice Department is conducting an investigation into Guidant’s handling of safety issues.
Sheller, Ludwig and Badey is currently investigating claims against Guidant Corporation related to recalled heart devices.