The FDA issued a Class I recall of the St. Jude Medical AMPLATZER TorqVue FX Delivery System due to the possibility of the distal end of the core wire to "fracture when exposed to a combination of certain cardiac anatomies and usage conditions." Use of the system, used in conjunction with the Amplatzer Occluder devices, should be halted immediately. Read the FDA Safety Alert.

Keywords: Heart, Medical Device Recalls, Septal Occluder Device

< Back to Listings