Implantable device recalls: are we throwing away the baby with the bath water?

ABSTRACT

Over the past year, there has been a sharp increase in the number of recalls, or `field safety corrective actions' concerning implantable defibrillators. This may be due to an actual rise in device or component-related problems (for which there is some evidence), overzealous reporting of potential problems (which is apparent), or most probably a combination of the two. In this day and age of increasing numbers of ICD implantations, it is essential that all concerned realise that ICDs are no more infallible than other man-made devices and that the incidence of complications is therefore likely to increase commensurately. It is also important to weigh the procedural risk of replacing the device against the risk not only of device failure, but more importantly related harm to the patient. Odds actually favour replacement in very few cases. Above all this demands critical attention to communication between stakeholders, medical, industry, patients and press. This article attempts to place a number of these issues in some perspective, and offer future directions for management of ICD recalls and safety actions.