Device recall
Z-1595-2011: AMPLATZER Sizing Balloon II, REF 9-SB-034, Sterile EO, AGA Medical Corporation…
FDA device recall · Class II · AGA Medical Corporation
Key facts
| Recall number (Z-number) | Z-1595-2011 |
|---|---|
| Recall event | 57819 |
| Product | AMPLATZER Sizing Balloon II, REF 9-SB-034, Sterile EO, AGA Medical Corporation, 5050 Nathan Lane North, Plymouth, MN 55442. The AMPLATZER Sizing Balloon II is intended for use in those patients with cardiovascular defects wherein accurate measurement of the defect is important to select the… |
| Product code | MJN |
| Recalling firm | AGA Medical Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 29, 2012 |
| 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