The U.S. Food and Drug Administration (FDA) just announced a Class I recall over St. Jude Medical’s Amplatzer TorqVue FX Delivery System. The device’s core wire may fracture, according to the recall notice.
A Class I designation is the agency’s most serious and involves a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
The new delivery system, said Bloomberg.com, is used in the treatment of a dangerous hole in the heart; however, the device could fracture in a small number of cases. The fracture may lead to serious damage, even death. Of note, last month, St. Jude received an FDA warning letter concerning manufacturing processes at one of its California factories.
According to the agency, 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. This recall involves all batches and model numbers of the Amplatzer TorqVue FX Delivery System, which was manufactured August 24, 2012 to September 24, 2012 and distributed October 1, 2012 to January 9, 2013.
Last month, St. Jude wrote to physicians concerning the Amplatzer TorqVue system recall after it found that the damage could take place in certain heart patients and advised doctors to stop using the device and remove it from inventory, said Bloomberg.com.
“If the device has already been used successfully, there is no cause for concern or additional action,” the company said in a statement. “St. Jude Medical is taking a conservative approach in removing all remaining inventory.” St. Jude also said that no serious injuries have occurred in connection with the recalled Amplatzer TorqVue system, which has been used in 120 patients.
The “Urgent Medical Device Recall Notice” also advised that St. Jude Medical plans to have its sales representatives perform site visits to assist with recall activities, including completion of its Product Reconciliation form and return of any unused product, the FDA said.
Doctors may use an older version of the delivery system to insert the device used to close a hole in the heart, said St. Jude spokeswoman, Amy Jo Meyer. The Amplatzer TorqVue FX Delivery System is used to assist in the attachment, load, delivery, and deployment of Amplatzer Occluder devices, which are used to close openings between the two upper chambers of the heart, the FDA explained.
St. Jude ceased its sales of the Riata lead, which is used to connect life-saving defibrillators to the heart. Those sales were stopped in 2010 after research revealed that the Riata’s wires could break through their insulation coating, which could potentially cause inappropriate shocks, said Bloomberg.com. Last year, St. Jude recalled its QuickSite and QuickFlex left-ventricular leads following reports that those wires could protrude from their insulation.