Amplatzer TorqVue FX Delivery System Recall Lawsuits. Parker Waichman LLP is currently investigating lawsuits on behalf of individuals who were injured due to the Amplatzer TorqVue FX Delivery System, which is used to help treat people with a hole in the heart.
Reports suggest that this device, which is manufactured by St. Jude Medical, can cause serious injuries when the core wire fractures. The U.S. Food and Drug Administration (FDA) has issued a Class I recall of the delivery system because of this risk.
If you or someone you know suffered injuries after using the Amplatzer TorqVue FX Delivery System, our attorneys would like to speak with you. Call Parker Waichman LLP today for a free, no-obligation evaluation of your case.
The Amplatzer TorqVue FX Delivery System is used to help treat a hole in the heart that, if left open, may permit blood clots to travel to the brain, causing a stroke.
On January 17, 2013, St. Jude Medical sent an “Urgent Medical Device Recall Notice” to its customers; the company advised consumers to stop using the device to remove it from their inventory.
On February 13, 2013, the U.S. Food and Drug Administration (FDA) issued new safety information on the product, announcing that the agency has informed healthcare professionals about a Class I recall of the Amplatzer delivery system.
The distal end of the core wire of the TorqVue FX Delivery System could potentially fracture
The agency stated that in some patients, “the distal end of the core wire of the TorqVue FX Delivery System could potentially fracture when exposed to a combination of certain cardiac anatomies and usage conditions.”
The recalled device was manufactured from August 24, 2012 to September 24, 2012 and distributed between October 1, 2012 and January 9, 2013.
A Class I recall is the FDA’s most serious recall status. It means that exposure to the Amplatzer can lead to serious health consequences, including death.
The Amplatzer recall is the not the first safety issue St. Jude has been faced with. Previously, the company had received a warning letter from the FDA over its manufacturing procedures at a California factory.
In 2010, the FDA issued another Class I recall for the company’s Riata defibrillator leads after reports suggested that the wires can break through the insulation coating. St. Jude also recalled the QuickSite and QuickFlex left-ventricular leads in 2012 following reports that these wires could also protrude from their insulation.
Need Legal Help Regarding Amplatzer TorqVue FX Delivery System?
If you or a loved one suffered injuries from St. Jude’s AMPLATZER TorqVue FX Delivery System, you may have valuable legal rights. Please fill out our online form or call 1(800)-YOURLAWYER (1-800-968-7529) to speak with one of our experienced defective medical device attorneys today.