Device recall
Z-0256-2007: Amplatzer Cardiac Septal Occluder delivery system Exchange Systems labeled as…
FDA device recall · Class II · AGA Medical Corporation
Key facts
| Recall number (Z-number) | Z-0256-2007 |
|---|---|
| Recall event | 36440 |
| Product | Amplatzer Cardiac Septal Occluder delivery system Exchange Systems labeled as follows: a) AMPLATZER Exchange System, Order no. 9-EXCH-6F-180/80, 9-EXCH-8F-180/80, 9EXCH-9F-45/80, 9-EXCH-12F-45/80. [Breakdown of order no. ''9-EXCH-6F180/80'' is as follows: 9-EXCH, French size (6F) - degree angle… |
| Product code | GBK |
| Recalling firm | AGA Medical Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 9, 2008 |
| PMA numbers | P020024 |
| 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