FDA Classifies Voluntary Physician Advisory Letter on Riata and Riata ST Silicone Defibrillation Leads as Class I Recall

St. Jude Medical, Inc., a global medical device company, recently announced that the U.S. Food and Drug Administration (FDA) has sent its voluntary medical device advisory letter to physicians instituting a Class I Recall regarding the performance of Riata and Riata ST Silicone Defibrillation Leads.  The classification of this recall is part of the process that follows any medical device advisory issued by a device manufacturer to physicians.  An estimated 79,000 Riata and Riata ST family of silicone leads remain active in patients in the U.S.  The company stopped distributing the Riata and Riata ST family of silicone leads in December, 2010.  The FDA has classified this recall as a Class I recall because of the potential risk of serious injury or patient death if affected devices malfunction.  The clinical implications of externalized conductors in a defibrillation lead without electrical anomalies are not fully known or understood at this time.  Externalized conductors can present as only a visual observation on x-ray or fluoroscopy without any associated clinical or device-related observations.  If the electrical intergrity of a lead were to be compromised, failure to deliver appropriate therapy, or the delivery of inappropriate therapy, could potentially occur, and could lead to a serious adverse event or death.  Reports to St. Jude Medical associated with extraction of a Riata lead with externalized conductors include two patient deaths and one serious injury (effusion requiring thoracotomy).  In addition, one patient death and one serious injury in patients with externalized conductors were reported, but were determined not to be due to the presence of externalized conductors.  The attorneys at Balkan & Patterson, LLP are experienced in class action litigation and will act to protect consumers against corporate wrongdoers. If you believe you have potential for a class action in relation to the performance of Riata and Riata ST Silicone Defibrillation Leads, please contact us immediately and we will review your case at no charge.

The law firm of Balkan & Patterson, LLP was founded in 2006 and is headquartered in Boca Raton, Florida, at 601 S. Federal Highway, Suite 302, with offices in Broward County. Mr. Balkan and Mr. Patterson can be contacted at (561) 750-9191. Additional information about Balkan & Patterson, LLP may be obtained from the firm’s website at www.balkanpatterson.com.