Device recall
Z-1101-2010: AGA Medical Corporation, Amplatzer TorqVue Delivery System 45-degree. REF…
FDA device recall · Class II · AGA Medical Corporation
Key facts
| Recall number (Z-number) | Z-1101-2010 |
|---|---|
| Recall event | 54369 |
| Product | AGA Medical Corporation, Amplatzer TorqVue Delivery System 45-degree. REF: 9-1TV10F45/80. Designed to facilitate the introduction of transvenous devices to chambers and coronary vasculature of the heart and for introducing therapeutic devices to a location within the peripheral vasculature. |
| Product code | DQY |
| Recalling firm | AGA Medical Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 29, 2012 |
| 510(k) numbers | K072313 |
| FEI number | 3005334138 |
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