FDA Issues Class 1 Recall of FX Delivery System
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.
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