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Learn about the FDA recall of the St. Jude Medical Riata defibrillator leads. Follow the latest news on the Riata recall and lawsuits against St. Jude Medical. Read about how our landmark U.S. Supreme Court victory benefited consumers across America. We represent people across America who were harmed by dangerous drugs and defective medical devices. If you or a loved one has been harmed by a defective Riata defibrillator lead, contact us to discuss your legal rights.
St Jude Riata Leads
St Jude Riata Leads

St. Jude Riata Recall

Lawyers Represent People Injured by St. Jude Medical Riata Defibrillator Leads

May 1, 2012—St. Jude Medical published a study that demonstrates problems associated with its Riata defibrillator leads. The FDA already issued a recall of the lead wires in December 2011.

The study indicated that there were 671 confirmed cases of problems associated with Riata and Riata ST defibrillator leads as of February 29, 2012. Adverse event reports often go underreported since it typically requires the doctor or patient to inform the company or the FDA of problems with particular device.

The Riata leads were criticized by Dr. Robert Hauser in an article published in HeartRhythm. Dr. Hauser (Minneapolis Heart Institute) concluded that the Riata leads failed at a higher rate than a comparable lead manufactured by Medtronic. Notwithstanding the fact that the FDA issued a recall, St. Jude Medical disputes Dr. Hauser's conclusions and has demanded a retraction of his article.

 

FDA Announces St. Jude Riata Defibrillator Lead Recall

December 21, 2011—The FDA announced a recall of St. Jude Medical Riata defibrillator lead wires following reports that the leads could wear through the silicone coating. The FDA classified its action as a Class I recall. A Class I recall is the most serious issued by the FDA and is reserved for "a situation in which there is a reasonable probability that the use of or exposure of a violative product will cause serious adverse health consequences or death.

Riata Defibrillator Leads

Failure of the silicone coating can result in the leads becoming loose in blood vessels near the heart. It also can cause malfunction of the device, including failure of the device to deliver pacing or defibrillation therapy.

The recall includes the following models numbers:

  • Riata (8F) Silicone Endocardial Defibrillation Leads
    Models: 1560, 1561, 1562, 1570, 1571, 1572, 1580, 1581, 1582, 1590, 1591, 1592
  • Riata ST (7Fr) Silcone Endocardial Defibrillation Leads
    Models: 7000, 7001, 7002, 7010, 7011, 7040, 7041, 7042
Your Health

What You Should Do

Your Health

If you have a St. Jude Medical Riata defibrillator lead implanted and you are concerned about your health, promptly consult your physician for an evaluation.

Your Legal Rights

If you have been injured as a result of a St. Jude Medical Riata defibrillator lead, you may be entitled to compensation.  You should act immediately to contact an attorney experienced in matters involving defective medical devices.
Defective Medical Device Lawyers

Our Lawyers Can Help

O'Steen & Harrison, PLC is handling legal claims on behalf of those harmed as a result of a St. Jude Medical Riata defibrillator lead. We invite you to contact us for a free, confidential consultation about your legal rights.

We represent patients throughout the United States.  We can help you, too, wherever you live.  We are paid only if we win your case, and you collect.

For free answers to your questions about St. Jude Medical defibrillator leads, please call us toll-free at 1-800-883-8888 or complete this online contact form.

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St. Jude Riata News

St. Jude Riata Heart Device Problems Persist • Reuters • May 1, 2012

St. Jude's Wiring Problem Persists • Wall Street Journal • April 30, 2012

More St. Jude Riata News Stories