WASHINGTON -- The FDA has issued a Class I recall for several models of endocardial defibrillation leads because of premature abrasion of the insulation, which may cause a device failure.
St. Jude Medical's Riata (8F) and Riata ST (7Fr) Silicone Endocardial Defibrillation Leads may wear out their silicone insulation prematurely, which externalizes the leads' conductors. This can cause electrical dysfunctions and the device may malfunction, no longer delivering life-saving therapy, an FDA statement said.
The leads connect an implantable cardioverter defibrillator, or cardiac resynchronization therapy defibrillator, to heart tissue, providing pacing and delivery of high-voltage therapy for ventricular arrhythmias.
St. Jude Medical issued an important product information letter to healthcare professionals on Dec. 15, 2010 that warned about the leads' potential failure. A second notice was sent on Nov. 18, 2011, which updated the failure rates raised in the initial notice, and included recommendations and alternative plans of action in the event a patient was implanted with an affected device.
The recall affects 20 model numbers of the two devices, including:
- Riata (8F): 1560, 1561, 1562, 1570, 1571, 1572, 1580, 1581, 1582, 1590, 1591, and 1592
- Riata ST (7Fr): 7000, 7001, 7002, 7010, 7011, 7040, 7041, and 7042
Class I recalls affect products with a reasonable probability of serious adverse events or death with use.