How to Respond to an Implantable Cardioverter-Defibrillator Recall

T he purpose of the implantable cardioverter-defibrillator (ICD) is to recognize and terminate abnormal heart rhythms and to provide protection from sudden cardiac death in atrisk patients.Ideally, the protection of the ICD can produce a feeling of safety for patients and families.The reliability and sustained performance of the ICD and its leads have become highly publicized issues with substantial media coverage and policy statements from medical societies.ICD technology has evolved tremendously in the past 25 to 30 years.Despite these advances, "no complex device can be 100% free of design, manufacturing, and performance flaws." 1 ICDs, like cars, are designed, created, manufactured, and provided to consumers but require monitoring to optimize their benefit.Unfortunately, some errors can be found only after the products are in use.Although ICD malfunctions and recalls are inevitable, they are rare.In fact, out of more than 415 000 ICDs implanted in the United States between 1990 and 2002, only 2% were extracted because of confirmed malfunction.2 ICDs are important life-extending devices that have saved many lives and will continue to save many more.The purpose of this article is to help ICD patients be prepared for and to decrease distress in the event of a recall.