St. Jude's Riata defibrillator lead -- a wire that connects the lifesaving device to the heart -- fails at a much higher rate than previously thought and has been recalled by the FDA. The Riata Lead recall is a Class I recall, the most serious form of recall.
The FDA has classified the St. Jude Riata Lead Recall as a Class I recall because of the potential risk of serious injury or patient death if affected devices malfunction.
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Riata and Riata ST leads connect an implantable cardioverter defibrillator (ICD) to the heart in order to monitor heart rhythms. ICD's can detect life-threatening heart rhythms and deliver an electrical shock from the ICD through the lead to the heart. ICD leads typically have layers of insulation that protect electrical conductor wires inside the lead.
Riata's manufacturer, St. Jude Medical Inc., recalled these leads on Nov. 28, 2011, due to premature erosion of the insulation around the electrical conductor wires, known as insulation failure. St. Jude Medical stopped selling these leads in late 2010 but more than 227,000 Riata leads had been distributed worldwide. According to St. Jude Medical, as of 2011, approximately 79,000 Riata leads remained implanted in patients in the United States.
Lead insulation failure may cause the ICD lead to malfunction. ICD lead malfunction may cause abnormal sensing or pacing, or delivery of inappropriate or no shock therapy, which could result in serious adverse events, including death.
The majority of Riata and Riata ST ICD leads, including those that show signs of electrical conductor migration or externalization on imaging, continue to function electrically and provide life-saving support. However, the FDA is concerned that Riata and Riata ST leads that show insulation abnormalities on imaging may be at greater risk of future electrical failure.
2/04/2013 NBC Chicago News Story
1/14/2013 FDA Warning Letter concerning the manufacturing of Riata Leads.
9/12/2012 The New York Times story Unpredictable Danger Looms Close to Heart
8/17/2012 Update: McSweeney / Langevin press release
8/17/2012 Update: Wall Street Journal article
8/16/2012 FDA Safety Communication
6/18/2012 McSweeney / Langevin press release
5/11/2012 Wall Street Journal story details the mental stress and anxiety facing individuals with these leads.
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