The pacemaker and implantable cardioverter defibrillator recall issue - a Canadian perspective.

In 2005, an unprecedented number of recalls were issued on pacemakers and implantable cardioverter defibrillators. While recalls in the cardiac rhythm device industry are not new, the sheer magnitude of potentially affected patients in 2005 led to a great deal of concern, frustration, and even anger. Physicians have, in many instances, been uncertain when (or if) to recommend device replacement in an environment where the magnitude of the risk and the potential consequences of device failure have not been well defined in a timely way. Doctors and patients are now calling for reform of postmarket analysis and reporting mechanisms. The present article provides a uniquely Canadian perspective on this international issue. Potential solutions include the development of a set of realistic and common expectations, a restoration of confidence in postmarket analysis and reporting mechanisms, increased data transparency, and an increased role for patient and physician groups.