St. Jude Recalls Heart Occluder Tool, 483 Prompts FOIA Suit Against FDA

St. Jude Medical is recalling a tool used to implant Amplatzer heart hole closure devices due to a potentially flawed wire, a notice posted Tuesday to the FDA’s website says. The Amplatzer TorqVue FX Delivery System helps to deliver and deploy Amplatzer Occluder devices in the heart. “In a small number of cases, the core wire could potentially fracture when exposed to a combination of certain cardiac anatomies and implant practices,” company spokeswoman Amy Jo Meyer explained. No serious injuries resulting from these fractures have been reported, Meyer said. The recalled products were distributed between Oct. 1, 2012, and Jan. 9. St. Jude has advised customers to stop using the delivery systems and remove them from inventory. Company sales reps will assist users with recall activities on site, the voluntary Class I recall notice states.
Devices & Diagnostics Letter