St. Jude Heart Defibrillator Riata Lead Recall
Product liability lawyer Eric Ratinoff is encouraging patients with St. Jude heart defibrillators to find out if theirs contains the recently recalled Riata lead.
According to a recent study, 15% of patients who received St. Jude's Riata defibrillator lead suffered an "insulation breach," also known as "insulation abrasion," wherein the wires that run from the defibrillator to the heart may protrude through the cable's outer coating.
The Riata lead touted ultra-thin wires and became a popular replacement by doctors for the Sprint Medtronics Fidelis lead was recalled in 2007 due to a risk that it would fracture. St. Jude Medical Inc. stopped selling the defective Riata leads in December 2010, however it is estimated that over 200,000 defective Riata leads had already been sold and/or implanted in patients worldwide. In December 2011, the FDA issued a Class 1 recall after discovering that the Riata leads were failing at a higher rate than originally reported.
Due to the difficulty in extracting faulty defibrillator leads, hundreds of thousands of patients with a St. Jude heart defibrillator will continue to live with the threat of their Riata lead failing. According to St. Jude's Riata recall notice, two patients died and one was seriously injured when surgeons attempted to remove their faulty Riata leads.
What are the risks of a St. Jude Heart Defibrillator Riata Lead with Insulation Abrasion?
A heart defibrillator with a defective lead may impede the device's ability to save its wearer's life, and it may also cause unnecessary shocking. If the lead malfunctions, it may interfere with the cables' ability to detect any rhythm problems in the heart. It may either prevent necessary shock therapy, or it may cause unwanted shocks. The FDA only issues Class 1 recalls when a device shows the potential to cause serious injury or death.
Contact an experienced medical device attorney
If you or a loved one has a St. Jude heart defibrillator and have experienced problems, or suspect your device may contain a recalled Riata lead, contact Eric Ratinoff for a free and confidential case evaluation by calling 888-285-3333 or filling out the contact form on this page.
For breaking news on the St. Jude Riata Lead Recall, visit our St. Jude Riata Recall website.