St. Jude (STJ) Reports FDA Has Classified VMD Advisory Letter for Riata as Class I Recall
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St. Jude Medical, Inc. (NYSE: STJ), announced that the U.S. Food and Drug Administration (FDA) has classified its voluntary medical device advisory letter to physicians from Nov. 28, 2011, regarding the performance of Riata and Riata ST Silicone Defibrillation Leads, as a Class I Recall.
The classification of this recall is part of the process that follows any medical device advisory issued by a device manufacturer to physicians. The FDA’s classification updates the recommendations provided in the Nov. 28, 2011 Physician Advisory Letter, which is available on the company’s website, www.sjmprofessional.com. 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 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. As communicated in the Physician 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 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 classification of this recall is part of the process that follows any medical device advisory issued by a device manufacturer to physicians. The FDA’s classification updates the recommendations provided in the Nov. 28, 2011 Physician Advisory Letter, which is available on the company’s website, www.sjmprofessional.com. 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 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. As communicated in the Physician 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 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.
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