| Class 1 Device Recall AMPLATZER TorqVue FX Delivery System | |
Date Initiated by Firm | January 18, 2013 |
Date Posted | February 11, 2013 |
Recall Status1 |
Terminated 3 on May 21, 2013 |
Recall Number | Z-0763-2013 |
Recall Event ID |
64155 |
510(K)Number | K121611 |
Product Classification |
Catheter, percutaneous - Product Code DQY
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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 MN 55117-1951
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For Additional Information Contact | 651-756-6526 |
Manufacturer 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. |
FDA Determined Cause 2 | Device Design |
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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = DQY
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