Device recall
Z-0052-2007: AMPLATZER PFO Occluder. Order No. 9-PFO-018. Device is not PMA approved in the…
FDA device recall · Class II · AGA Medical Corporation
Key facts
| Recall number (Z-number) | Z-0052-2007 |
|---|---|
| Recall event | 35814 |
| Product | AMPLATZER PFO Occluder. Order No. 9-PFO-018. Device is not PMA approved in the US. 18mm Sterile EO. The AMPLATZER PFO Occluder is a self-expandable, double disc device made from a Nitinol wire mesh. AGA Medical Corporation, 682 Mendelssohn Avenue, Golden Valley, MN 55427 USA. |
| Product code | MLV |
| Recalling firm | AGA Medical Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 1, 2007 |
| FEI number | 3005334138 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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