Washington, DC: St. Jude Medical has issued a recall of its Riata ST (7Fr) Silicone Endocardial Defibrillation Leads, models: 7000, 7001, 7002, 7010, 7011, 7040, 7041, 7042: and Riata (8F) Silicone Endocardial Defibrillation Leads, models: 1560, 1561, 1562, 1570, 1571, 1572, 1580, 1581, 1582, 1590, 1591, 1592. The distribution dates are: June 2001 to December 31, 2010.
The leads connect an implantable cardioverter defibrillator (lCD) or cardiac resynchronization therapy defibrillator (CRT-D) to cardiac tissue in order to monitor and regulate a patient' heart rate by providing pacing and delivery of high voltage therapy for ventricular arrhythmias.
The leads are being recalled because failures associated with lead insulation abrasion on the St. Jude Medical Riata and Riata ST Silicone Endocardial Defibrillation Leads may cause the conductors to become externalized. If this occurs, this product may cause serious adverse health consequences, including death.
