The Amplatzer TorqVue FX Delivery System is being recalled by St. Jude Medical Cardiovascular and Ablation Technologies Division because the distal end of the core wire of the TorqVue FX Delivery System could potentially fracture. This product may cause serious adverse health consequences, including death.
The Amplatzer TorqVue FX Delivery System is used to assist the attachment, loading, delivery, and deployment of Amplatzer Occluder devices. Amplatzer Occluder devices are used to close openings between the two upper chambers of the heart.
This product was manufactured August 24, 2012 to September 24, 2012 and distributed October 1, 2012 to January 9, 2013.
The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
See the Recall