St. Jude Medical Recalls Heart Fix Device

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.
St. Jude Medical Inc. initiated the recall (considered the most serious type) on Jan. 17 with a letter advising customers to stop using the Amplatzer TorqVue FX system and remove the device from their inventories. The products were manufactured between Aug. 24 and Sept. 24, and distributed Oct. 1-Jan. 9. The St. Paul, Minn.-based medtech behemoth is sending sales reps to help customers complete product reconciliation forms and return unused devices made and distributed during those times. A company spokeswoman said the system has been used in 120 patients since it was introduced last year.

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 now sidelined, doctors are advised to 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.