According to a recent study, approximately 15% of heart surgery patients with a St. Jude’s Riata defibrillator lead have suffered an “insulation breach,” or “insulation abrasion,” in which the wires running from the implanted defibrillator to the heart may protrude through the cable’s shield or coating.
Due to its “ultra thin wires,” the Riata lead became a popular replacement by doctors for the Sprint Medtronics Fidelis lead, which was recalled in 2007 due to a risk that it would fracture. In December 2010, however, St. Jude Medical Inc. stopped selling the defective Riata leads, after an estimated 200,000+ defective Riata leads had already been sold and potentially implanted in people all over the world. In December 2011, the FDA issued a Class 1 recall after discovering that the Riata leads were failing at an unacceptably high rate.
Because it is extremely difficult to extract faulty defibrillator leads from a patient’s heart, hundreds of thousands of patients with a St. Jude heart defibrillator will go on living with a constant threat that their Riata lead could fail at any given moment. 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 defective St. Jude Riata Lead?
A heart defibrillator with a defective lead may impair 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 Ratinofffor a free and confidential case evaluation by calling 888-285-3333 or filling out the contact form on this page.