Drug recall
St. Jude Medical, AGA Medical corporation, AMPLATZER¿ TorqVue¿ FX Delivery System. Model #'s: 9-ITVFX06F45/60…
FDA recall event 64155 · Class I · St Jude Medical Inc
Key facts
| Event ID | 64155 |
|---|---|
| Recall numbers | Z-0763-2013 |
| Recalling firm | St Jude Medical Inc |
| Product type | Devices |
| Products | 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… |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | Jan 18, 2013 |
| Report date | Feb 20, 2013 |
| Termination date | May 21, 2013 |
| City | Saint Paul |
| State | MN |
| Country | United States |
| FEI number | 2126673 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: