The Food and Drugs Administration (FDA), United States posted a medical device safety alert concerning AMPLATZER TorqVue FX Delivery System [Model no.: 9-ITVFX06F45/60, 9-ITVFX07F45/60, 9-ITVFX007F45/80, 9-ITVFX08F45/60, 9-ITVFX08F45/80, 9-ITVFX09F45/80, 9-ITVFX10F45/80, 9-ITVFX12F45/80, 9-ITVFX13F45/80] manufactured by St Jude Medical. The product was manufactured 24 August 2012 to 24 September 2012 and distributed 1 October 2012 – 9 January 2013.
In a small number of cases, 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 manufacturer advised customers to stop using the device and remove it from their inventory.
According to the local supplier, the affected devices were not distributed in Hong Kong.
For details, please visit the following FDA website:
http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm339458.htm
If you are in possession of the product, please contact your supplier for necessary actions.
Posted on 14 February 2013