The St. Jude Medical product portfolio consists of “implantable cardioverter defibrillators (ICDs), cardiac resynchronization therapy (CRT) devices, pacemakers, electrophysiology catheters, mapping and visualization systems, vascular closure devices, structural heart products, spinal cord stimulation and deep brain stimulation devices.” The FDA has issued a recall of St. Jude ICD leads.
Cole Petrochko has reported for MedPage Today “FDA Recalls St. Jude ICD Leads.” There has been a recall by the FDA for several models of endocardial defibrillation leads due to premature abrasion of the insulation, which may cause a device failure. It has been found that St. Jude Medical’s Riata (8F) and Riata ST (7Fr) Silicone Endocardial Defibrillation Leads may wear out their silicone insulation prematurely, which than externalizes the leads’ conductors.
The FDA statement said that this can cause electrical dysfunctions and the device may than malfunction, resulting in the failure of the device to deliver life-saving therapy. These leads connect an implantable cardioverter defibrillator, or cardiac resynchronization therapy defibrillator, to heart tissue, which provides pacing and delivery of high-voltage therapy for ventricular arrhythmias. Healthcare professionals were sent an important product information letter by St. Jude Medical on December 15, 2010 that warned about the leads’ potential failure.
There was a second notice sent on November 18, 2011, which updated the failure rates which were raised in the initial notice, and included recommendations and alternative plans of action in the event a patient was implanted with an affected device. This recall affects 20 model numbers of the two devices, which include “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.”
In a news release on December 15, 2011 St. Jude Medical issued a news release advising 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. Class I recalls affect products which have a reasonable probability of serious adverse events or death with use.
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Mandel News Service