St. Jude Medical, AGA Medical corporation, AMPLATZER TorqVue FX Delivery System. Model #'s: 9-ITVFX06F45/60, 9-ITVFX07F4
FDA device recall Z-0763-2013 · posted 2013-02-11 · Terminated
Recall details
- Recalling firm
- St Jude Medical Inc
- 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 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- DQY
- Quantity affected
- 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, V
- Date initiated
- 2013-01-18
- Date posted
- 2013-02-11
- Date terminated
- 2013-05-21
- Location
- Saint Paul, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AMPLATZER TORQVUE FX (K121611) | Aga Medical Corporation | 2012-08-23 |