Device recall
Z-2193-2008: AMPLATZER Sizing Balloon II, REF 9-SB-24. Sterile EO. AGA Medical Corporation…
FDA device recall · Class II · AGA Medical Corporation
Key facts
| Recall number (Z-number) | Z-2193-2008 |
|---|---|
| Recall event | 48650 |
| Product | AMPLATZER Sizing Balloon II, REF 9-SB-24. Sterile EO. AGA Medical Corporation, 682 Mendelssohn Avenue, Golden Valley, MN 55427 USA. Manufactured in U.S.A. A triple lumen balloon catheter with 3 radiopaque marker bands located inside the balloon to allow for radiographic measurement. The center of… |
| Product code | MJN |
| Recalling firm | AGA Medical Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 13, 2010 |
| 510(k) numbers | K053440 |
| FEI number | 3005334138 |
At a glance
- 1–9 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