The U.S. Food and Drug Administration recalled Riata Defibrillator Leads because they can potentially injure or kill patients. The devices are used to connect defibrillators to the heart. Wires inside some leads can penetrate the insulation and compromise the device’s integrity. The devise is manufactured by St. Jude Medical, who sent a letter to doctors on November 28, 2011 informing them that the wires had a higher failure rate than was previously known.
The F.D.A. deemed the letter a Class 1 recall, its most serious designation, because of the potential risks.
An estimated 79,000 Riata and Riata ST family of silicone leads remain active in patients in the U.S. The affected model numbers are Riata (8F) Silicone Endocardial Defibrillation Leads (Models 1560, 1561, 1562, 1570, 1571, 1572, 1580, 1582,1590, 1591 and 1592), and Riata ST (7Fr) Silicone Endocardial Defibrillation Leads (Models 7000, 7001, 7002, 7010, 7011, 7040, 7041 and 7042).
If you have been injured or have a concern about the Riata Defibrillation Lead contact our San Francisco Bay Area medical device attorneys at Strick Injury Law and Mediation today.
St. Jude Medical acknowledges that the clinical implication of leads with electrically intact externalized conductors are not fully known at this time.
BAY AREA MEDICAL DEVICE ATTORNEYS: RIGHTING THE WRONG FOR INJURIES CAUSED BY RIATA DEFIBRILLATION LEADS.
CALL Strick Injury Law and Mediation FOR A FREE CONSULTATION IF YOU BELIEVE YOU HAVE BEEN INJURED AS A RESULT YOUR USE OF THE ST. JUDE MEDICAL RIATA DEFIBRILLATION LEAD.