St — Class I medical device recall Z-0763-2013
Terminated recall by St Jude Medical Inc, reported 2013-02-20, distributed nationwide. The distal end of the core wire of the TorqVue FX Delivery System could potentially fracture when exposed to a
| Recall number | Z-0763-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | St Jude Medical Inc, Saint Paul, MN, United States |
| Recall initiated | 2013-01-18 |
| Classified | 2013-02-11 |
| Reported by FDA | 2013-02-20 |
| Terminated | 2013-05-21 |
| Distributed | Nationwide (US) |
| Quantity | 635 |
| Reason classes | device malfunction |
| Model numbers | 9-ITVFX007F45/80, 9-ITVFX06F45/60, 9-ITVFX07F45/60, 9-ITVFX08F45/60, 9-ITVFX08F45/80, 9-ITVFX09F45/80, 9-ITVFX10F45/80, 9-ITVFX12F45/80, 9-ITVFX13F45/80 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0763-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.