The U.S. Food and Drug Administration (FDA) has classified a recent advisory letter regarding Riata and Riata ST Silicone Defibrillation Leads to be a Class I recall.
On November 28, 2011, St. Jude Medical, Inc., a global medical device company, sent an advisory letter to physicians 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 to physicians by a manufacturer.
The FDA’s classification updates the recommendations provided in the November 28th Physician Advisory Letter. 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 affected model numbers are 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).
The recall has been issued because of the potential risk of serious injury or patient death if affected devices malfunction. As communicated in the advisory letter, 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 integrity 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 of injury include two patient deaths and one serious injury (effusion requiring thoracotomy). There was one additional patient death, as well as a serious injury in patients with externalized conductors were reported, but were determined not to be due to the presence of externalized conductors.