FDA recalls potentially lethal Riata Defibrillation Leads

FDA recalls potentially lethal Riata Defibrillation LeadsOn December 14, 2011, the U.S. Food and Drug Administration announced that St. Jude Medical, Inc., a global manufacturer of medical devices, stated it had issued a voluntary medical device Class I recall of Riata and Riata ST Silicone Defibrillation Leads.

As a Class I Recall, the devices have a potential risk of serious injury or patient death if they malfunction while being used. The company stated the clinical implications of externalized conductors in a defibrillation lead are not currently well known. However, if the electrical integrity of a lead is compromised, it could lead to the failure to identify and deliver proper therapy, which in turn could result in a serious adverse health event or death.

According to Heart Wire, the defect includes wires inside some leads that could potentially penetrate their insulating layer, causing unnecessary shocks or failing to deliver necessary shocks.

The number of affected leads is thought to have risen by about one-third in the last year, although it remains under 1 percent. 

St. Jude made the recall after two patient deaths and one serious injury allegedly arose that were linked to externalized conductors.

The company stated that more data are needed to determine what specific action should be taken by select patients using the products. However, patients who require more frequent defibrillation or who use pacemakers may be at a greater risk for serious injury or death.

"At this time, no blanket statement can be made about clinical recommendations. Until more data are collected, physicians should follow standard practice of care to manage their patients with Riata silicone leads," said Dr. Anne Curtis, professor and chair of Medicine at the University at Buffalo and a member of St. Jude Medical's Medical Advisory Board.

Curtis added that in the next several weeks, two public meetings will be held to discuss the affected products and consider clinical recommendations.