FDA Device recall Z-0763-2013
St. Jude Medical, AGA Medical corporation, AMPLATZER¿ TorqVue¿ FX Delivery System
- FDA Device
- Class I
- terminated
- Published 2013-02-20
On 2013-02-20 the FDA classified a Class I recall of St. Jude Medical, AGA Medical corporation, AMPLATZER¿ TorqVue¿ FX Delivery System by St Jude Medical, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0763-2013 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2013-01-18 |
| Published | 2013-02-20 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | St Jude Medical |
| Distribution | US |
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
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.
Identifiers
| code_info | all batches |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0763-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.