Z-0763-2013 Class I Terminated
FDA device recall Z-0763-2013 was initiated by St Jude Medical Inc on Jan 18, 2013 and is designated Class I. 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. The recall status is terminated (terminated May 21, 2013). Affected quantity: 635.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 20, 2013
- Initiation Date
- Jan 18, 2013
- Termination Date
- May 21, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 635
Product Description
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.
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 Pattern
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.
Code Information
all batches
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0763-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026