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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 1 Recall
AMPLATZER® TorqVue® FX Delivery System		see related information
Date Posted February 11, 2013
Recall Number Z-0763-2013
Product St. Jude Medical, AGA Medical corporation, AMPLATZER® TorqVue® FX Delivery System. Model #'s: 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. Cardiac surgical instrument, used to close atrial septal defects between the right and left atriums.
Code Information all batches
Recalling Firm/
Manufacturer		 St Jude Medical Inc
177 E County Road B
Saint Paul, Minnesota 55117-1951
Consumer Instructions Contact the recalling firm for information
Reason for
Recall		 The distal end of the core wire of the TorqVue FX Delivery System could potentially fracture when exposed to a combination of certain cardiac anatomies and usage conditions.
Action St. Jude Medical sent an "URGENT MEDICAL DEVICE RECALL NOTICE" dated January 18, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers were advised to discontinue use of the device and remove it from inventory. Customers should contact their SJM sales representative for questions relating to this recall.
Quantity in Commerce 635
Distribution Nationwide Distribution-including DC and the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TX, VA, WA, and WI.
 
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