St. Jude Riata Lead attorneys Rhett McSweeney and David Langevin are providing free legal consultations to individuals and families injured or harmed as a result of the St. Jude Riata Leads that are the subject of a Class I FDA Recall. 1-800-888-4425.
St. Jude’s Riata Leads
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.
Risks / Side Effects of the Riata Leads
- A heart defibrillator with a defective lead may impede the device’s ability to save the person’s life;
- It may cause unnecessary shocking;
- It may interfere with the cables’ ability to detect any rhythm problems in the heart; or
- It may either prevent necessary shock therapy or cause unwanted shocks.
FDA Recall of St. Jude’s Riata Leads Due to Lead Failure
The FDA has classified this recall as a Class I recall because of the potential risk of serious injury or patient death if affected devices malfunction.
Products: Riata and Riata ST Silicone Endocardial Defibrillation Leads
Riata (8F) Silicone Endocardial Defibrillation Leads
Models: 1560, 1561, 1562, 1570, 1571, 1572, 1580, 1581, 1582, 1590, 1591, 1592
Riata ST (7Fr) Silicone Endocardial Defibrillation Leads
Models: 7000, 7001, 7002, 7010, 7011, 7040, 7041, 7042
Did You or a Loved One Experience Any of The Above Symptoms or Injuries?
Please feel free to contact one of our St. Jude Riata lead lawyers at 1-800-888-4425. If you prefer, feel free to use the form to the right, one of our Riata lead attorneys will evaluate your claim and contact you shortly. Thank you.
FDA Riata Lead Safety Comunication: Premature Insulation Failure in Recalled Riata Implantable Cardioverter Defibrillator (ICD) Leads Manufactured by St. Jude Medical, Inc.
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.
Riata Lead News
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.
5/11/2012 Minneapolis Star Tribune article discusses the failure rates of leads manufactured by the Minnesota based company St. Jude Medical.
St. Jude Medical Communication
Our Riata lead attorneys handle cases throughout the entire United States: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin and Wyoming.
Our Riata lead lawyers handle cases in the following cities: New York, Los Angeles, Chicago, Houston, Philadelphia, San Diego, San Antonio, Dallas, San Jose, Detroit, Jacksonville, San Francisco, Indianapolis, Austin, Columbus, Fort Worth, Charlotte, Memphis, Baltimore, El Paso, Boston, Milwaukee, Denver, Seattle, Nashville, Washington, Las Vegas, Portland, Louisville, Oklahoma City, Tucson, Atlanta, Albuquerque, Fresno, Sacramento, Long Beach, Mesa, Kansas City, Omaha, Cleveland, Virginia Beach, Miami, Oakland, Raleigh, Tulsa, Minneapolis / St. Paul, Colorado Springs, Honolulu, Arlington, Wichita, St. Louis, Tampa, Santa Ana, Anaheim, Cincinnati, Bakersfield, Aurora, New Orleans, Lexington, Pittsburgh, and Buffalo.