Device recall
Z-0464-06: AMPLATZER Duct Occluder, Order No. 9-PDA-006, Device Size 10/8mm, Length 8 mm…
FDA device recall · Class III · AGA Medical Corporation
Key facts
| Recall number (Z-number) | Z-0464-06 |
|---|---|
| Recall event | 33406 |
| Product | AMPLATZER Duct Occluder, Order No. 9-PDA-006, Device Size 10/8mm, Length 8 mm. Sterile EO. Single Use Only. Manufactured by AGA Medical Corporation, 682 Mendelssohn Avenue, Golden Valley, MN 55427 USA. The AMPLATZER Duct Occluder is a self-expandable device made from a Nitinol wire mesh. A retention… |
| Product code | MAE |
| Recalling firm | AGA Medical Corporation |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Dec 26, 2006 |
| FEI number | 3005334138 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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