St. Jude Medical Inc. recalled a new delivery system used to treat people with a dangerous hole in the heart after discovering the device could fracture in a small number of cases, U.S. regulators said.
The core wire in the Amplatzer TorqVue FX Delivery System may fracture, causing serious damage and perhaps death, the Food and Drug Administration said today in a notice on its website. The Class 1 recall, considered the most serious type, was initiated on Jan. 18, the agency said.
St. Jude received an FDA warning letter last month for its manufacturing processes at a California factory. The company stopped selling its Riata lead used to connect life-saving defibrillators to the heart in 2010 after research showed the wires could break through their insulation coating, potentially causing appropriate shocks. St. Jude last year recalled the QuickSite and QuickFlex left-ventricular leads after reports that those wires could protrude from their insulation.
St. Jude said it told physicians about the voluntary recall of the Amplatzer TorqVue system last month in a letter after discovering the damage could occur in certain heart patients. No serious injuries have occurred, the St. Paul, Minnesota-based company said. The letter told doctors to stop using the device and pull it from their inventory.
“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 declined less than 1 percent to $42.60 at the close in New York. The company’s shares fell less than 1 percent in the past 12 months.
Doctors are able to use an older version of the delivery system to insert the device used to close a hole in the heart, said Amy Jo Meyer, a company spokeswoman. The treatment to close the hole is designed to prevent blood clots from traveling to the brain and causing strokes.
The new system has been used in 120 patients, the company said.