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U.S. Department of Health and Human Services

Class 1 Device Recall AMPLATZER TorqVue FX Delivery System

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  Class 1 Device Recall AMPLATZER TorqVue FX Delivery System see related information
Date Initiated by Firm January 18, 2013
Date Posting Updated 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
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
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

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.
510(K) Database 510(K)s with Product Code = DQY and Original Applicant = AGA MEDICAL CORPORATION
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