ICD recall update
This article was originally published in The Gray Sheet
Executive Summary
FDA supports Boston Scientific's decision to issue a "Dear Doctor" letter June 23 recalling nearly 50,000 Guidant pacemakers and implantable defibrillators, 27,200 of which have already been implanted. FDA met with the company recently to discuss the public notification of a potential capacitor malfunction. The agency is "closely monitoring" the situation, it said in a July 11 statement. Boston Scientific CEO Jim Tobin signaled following the recall that Guidant's device issues run deeper than poor communication (1"The Gray Sheet" July 3, 2006, p. 14). The company will continue its investigation of the problem over the next 60 days...