Device recall
Z-0763-2013: St. Jude Medical, AGA Medical corporation, AMPLATZER TorqVue FX Delivery System…
FDA device recall · Class I · St Jude Medical Inc
Key facts
| Recall number (Z-number) | Z-0763-2013 |
|---|---|
| Recall event | 64155 |
| 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… |
| Product code | DQY |
| Recalling firm | St Jude Medical Inc |
| Recall class | Class I |
| Status | Terminated |
| Termination date | May 21, 2013 |
| 510(k) numbers | K121611 |
| FEI number | 2126673 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database