St. Jude Medical Recalls Heart Fix Device
Posted on February 13, 2013 @ 03:34 pm
Talk about déjà vu. St. Jude Medical Inc. has recalled a new device that repairs a congenital heart defect after discovering its core wire potentially could fracture.
The U.S. Food and Drug Administration (FDA) issued a Class I (highest-risk) recall for the Amplatzer TorqVue FX Delivery System, a device used to treat patent foramen ovale, or a naturally occurring hole in the heart, formed during fetal development when the septum fails to completely seal. The defect potentially allows blood clots to travel through the heart and eventually to the brain, causing a stroke.
The recall really is more of a precautionary measure on St. Jude’s part. While no serious injuries have been reported, the distal end of the Amplatzer TorqVue’s core wire fractured in a “small number of cases” involving certain cardiac anatomies and implant practices. The malfunction, according to the FDA, could have serious consequences and potentially could be fatal.
But such consequences are highly unlikely, St. Jude Medical contends. “If the device has already been used successfully, there is no cause for concern or additional action,” the company said in a prepared statement. “St. Jude Medical is taking a conservative approach in removing all remaining inventory.”
With the new system sidelined, doctors can continue using the previous version of the TorqVue, which features a different design.
The Amplatzer TorqVue system is the third product in three years to be pulled from the market over potentially malfunctioning wires. In 2010, St. Jude stopped selling its Riata lead used to connect life-saving defibrillators to the heart after research showed the wires could break through their insulated coating, possibly causing shocks. Last year, the company recalled its QuickSite and QuickFlex left-ventricular leads after reports that those wires also could protrude from their insulation.
Please visit our sister sites:
The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.