In December 2011, the U.S. Food and Drug Administration (FDA) issued a Class I recall for the St. Jude Riata and the Riata ST Silicone Endocardial Defibrillator Leads. A Class I recall is the most serious type of recall the agency issues, and means the recalled drug or device can cause severe injury or death.
Although issued over a year ago, many patients are unaware still of the initial FDA recall.
St. Jude estimates that almost 20 percent of patients may have a defective defibrillator design where internal cables poking through the outer casing of the leads cause unwanted shocks to patients.
In 2012, the FDA encouraged all Riata patients to undergo imaging tests to determine if their implanted device was failing, and, if so, recommended removal.
Some patients are opting to have it taken out even if their lead is not failing, though removing the device could also be dangerous for some patients.