Here We Go Again — Another Failure of Postmarketing Device Surveillance

Abstract

The goal of postmarketing surveillance of medical devices is to enhance public health by gathering information about the incidence of adverse experiences with devices. However, patients in the United States continue to be exposed to underperforming and potentially hazardous medical devices after they have been approved by the Food and Drug Administration (FDA), despite multiple recalls and some tragic adverse events. The most recent example is the class I recall (a designation indicating a risk of serious injury or death) of the Riata and Riata ST implantable cardioverter–defibrillator (ICD) leads (St. Jude Medical), which are implanted in approximately 79,000 patients in the United States alone.¹