St. Jude Medical's Riata Leads Recalled Because of the Potential Risk of Serious Injury or Patient Death if the Device Malfunctions
Published: Jun 22, 2012
Christopher Ellis, M.D. of the Vanderbilt University Medical Center, said his group of doctors decided to recommend patients remove all leads with frayed wires visible on X-rays, even if they are working.
Riata Leads were recalled December 14, 2011 as part of a FDA Class I Recall. According to the FDA recall, medical advisers noted a higher-than-normal rate of insulation failure, called externalization. Affected model numbers include the Riata (8F) Silicone Endocardial Defibrillation Leads (Models 1560, 1561, 1562, 1570, 1571, 1572, 1580, 1581, 1582, 1590, 1591, and 1592), and the Riata ST (7Fr) Silicone Endocardial Defibrillation Leads (Models 7000, 7001, 7002, 7010, 7011, 7040, 7041, and 7042).
Attorneys at the law firm McSweeney / Langevin are currently offering individuals free legal advice concerning the rights of patients with these devices. McSweeney / Langevin can be reached at 1-800-888-4425 or info@WeStrikeBack.com.