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.
This recall has been terminated (originally issued February 11, 2013).
- Company
- St Jude Medical Inc
- Recall Initiated
- January 18, 2013
- Posted
- February 11, 2013
- Terminated
- May 21, 2013
- Recall Number
- Z-0763-2013
- Quantity
- 635
- Firm Location
- Saint Paul, MN
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
all batches
Root Cause
Device Design
Action Taken
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.