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The St. Jude Riata and Riata ST implantable cardioverter defibrillator (ICD) leads have been recalled because of design defects, which may allow the electrodes to poke through the insulation, putting patients at risk of problems with their defibrillator.
STATUS OF ST. JUDE RIATA LAWSUITS: A number of individuals throughout the United States have filed a St. Jude Riata lead lawsuit after experiencing complications where they suffered unnecessary shocks, required surgery to remove the recalled leads or had their defibrillator fail.
OVERVIEW: The St. Jude Riata and Riata ST leads are small wires used to connect an implantable cardiac defibrillator (ICD) to the heart. The leads monitor the heart rhythms and are designed to deliver a life-saving shock if needed to restore the heart to normal rhythms.
Due to manufacturing and design problems, the St. Jude Riata leads are prone to fail within a few years, with the small wire poking through the insulation. This could cause individuals to experience unnecessary shocks or cause the ICD to fail to deliver a necessary charge when needed.
Approximately 80,000 of the leads were still in patients at the time of the recall, leaving these individuals at risk of serious and potentially life-threatening complications.
ST. JUDE RIATA LEAD PROBLEMS: A number of articles posted on this website have highlighted and outlined the problems with St. Jude Riata leads that were implanted in patients throughout the United States.
- St. Jude Riata Defibrillator Lead Recall Issued (12/19/2011). Describing how the FDA classified a November 2011 warning letter sent to physicians and the company’s 2010 decision to halt sales for Riata leads as a Class I Medical Device Recall, suggesting that continued use of the leads poses a substantial risk of serious injury or death.
- Study presented at American College of Cardiology meeting in Chicago highlighted the Serious Risk Presented by Recalled St. Jude Defibrillator Leads (3/26/2012), highlighting how the defective leads may fail in multiple ways and pose a serious risk for patients.
- St. Jude QuickSite and QuickFlex CRT Leads Also Identified As Having Problems (4/5/2012). St. Jude announced that it will halt sales for these leads used in defibrillators known as cardiac resynchronization therapy (CRT) devices, due to similar insulation problems. At least 39 confirmed reports were identified where the conductors on St. Jude QuickSite and QuickFlex CRT leads pocked through the insulation.
- A large study presented at a meeting of the Heart Rhythm Society in Boston found that St. Jude Defibrillator Lead Failures May Be Widespread (5/14/2012). Out of 712 devices identified in a seven hospital study, researchers found at least 67 had failed by the end of December 2011. When x-ray images were reviewed for 110 of the patients, researchers found that the small lead wires had pierced through the insulation in about 25% of the cases.
- St. Jude Durata Lead Found to Have Similar Problem (6/13/2012). According to an adverse event report submitted to the FDA, one of St. Jude’s newer Durata leads was also found to have the conductor poking through the insulation in at least one patient.
- Research found that St. Jude Riata Problems Often Involve Large Diameter Leads (7/17/2012), with a 24% chance the insulation on the conducts of those leads may fail, compared to a 9.3% failure rate among small diameter St. Jude Leads.
- FDA Has Recommended X-Ray Monitoring Due to the Risk of St. Jude Riata Lead Insulation Failure (8/17/2012). Individuals with a recalled lead have been advised to obtain imaging exams, as well as other steps to monitor for problems. The FDA also ordered St. Jude to include several newer leads, including the Durata and Riata ST Optim, in additional studies that were ordered to evaluate the risk of problems
- St. Jude Defibrillator Lead Problems May Impact Newer Leads As Well (8/22/2012). According to a study published in the medical journal Europace, similar insulation problems have been identified with the St. Jude Riata ST Optim and St. Jude Durata leads, which feature redesigned insulating materials, with a mix of silicone and polyurethane.
ST. JUDE RIATA LAWSUIT ALLEGATIONS: The following articles provide additional information about the allegations and claims raised in various lawsuits over St. Jude leads:
- St. Jude Class Action Lawsuit Filed Over Defibrillator Lead Problems (6/18/2012). Investors filed a class action against St. Jude Medical alleging that the manufacturer artificially inflated it’s stock value by withholding information about problems with St. Jude Riata and QuickFlex leads.
- St. Jude Riata Lead Lawsuit Filed Over Failed Defibrillator Lead Wire (7/19/2012). A Connecticut man filed a lawsuit after his lead failed just over three years after it was implanted, requiring invasive surgery to remove and replace the small wire connecting his ICD to his heart.
According to allegations raised in lawsuits over St. Jude Riata leads:
- St. Jude Riata leads feature inconsistent insulation, which can cause the insulation to wear thinner at certain parts of the lead.
- Friction and abrasion may have been increased by inconsistent application of a lubricous interface between the inner and outer insulation.
- St. Jude Riata leads may have reduced strength of the silicone insulation due to a failure to properly cure and sterilize during the manufacturing process.
- St. Jude Riata leads may not have been crimped with a controlled and uniform degree of force, which could result in an insecure crimp over the length of the lead.
Potential claims are being reviewed by St. Jude Riata recall lawyers on behalf of individuals throughout the United States. Submit information about problems experienced by yourself, a friend or family member to determine whether financial compensation may be available through a product liability lawsuit.