St. Jude Medical Inc. sent a letter to physicians warning of problems with Riata and Riata ST leads, which connect an implantable cardioverter defibrillator (ICD) to the heart in order to monitor heart rhythms, on November 28, 2011. The FDA later classified the letter as a Class I Recall, the most serious type of recall – for products or devices that may cause serious adverse health consequences or death. St. Jude had already stopped selling these leads in late 2010, after more than 227,000 had been distributed worldwide. The FDA reported that, as of 2011, approximately 79,000 Riata leads remained implanted in patients in the US. The FDA, concerned that the Riata and Riata ST leads that show insulation abnormalities on imaging may be at greater risk of future electrical failure, recommends that physicians image Riata and Riata SST implanted leads to assess for externalization or other visible insulation abnormalities.
New York Times reported in its March 27, 2012, issue that at least 22 deaths were caused by the defective wires. Another eight patients died during procedures to remove the wires. Dr. Robert Hauser, author of the study, said the number of deaths was small compared with the number of patients who had these models of wires. However, “because it may be catastrophic, we need to be paying more attention to what are the electrical signs that might help us identify patients who are at risk,” he said.