In December 2011, the U.S. Food and Drug Administration (FDA) issued a Class I recall for St. Jude Riata and the Riata ST Silicone Endocardial Defibrillator Leads. A Class I recall is the most serious type of recall that the agency issues, this means that the recalled drug or device can cause patients severe injuries or death.
Although, the FDA issued the recall over a year ago many patients are unaware of it. It is believed that approximately 128,000 people still have this device implanted in them. St. Jude estimates that almost 20 percent of patients may have a defective defibrillator. The internal cables are poking through the outer casing of the leads causing unwanted shocks to patients.
In 2012, the FDA recommended that all patients with the Riata to undergo imaging to see if the lead was failing. Patients that have a failing device are recommended to have it removed.
Some patients are opting to have it remove, even if their lead is not failing. However, removing the device could also be dangerous from some patients.
If you or a loved one has been injured by a Riata Lead, you may be eligible to file a product liability lawsuit. Contact The Eichholz Law Firm today to learn about the legal rights available to defective product victims.
To speak with an attorney about your injury, fill out the Free Case Review form.