Device recall
Z-2192-2008: AGA Medical Corporation AMPLATZER Delivery System, 10 French, 45 Degree Angle…
FDA device recall · Class II · AGA Medical Corporation
Key facts
| Recall number (Z-number) | Z-2192-2008 |
|---|---|
| Recall event | 48650 |
| Product | AGA Medical Corporation AMPLATZER Delivery System, 10 French, 45 Degree Angle Curve, 80 Usable Length (cm), REF 9-DEL-10F-45/80. Sterile EO. AGA Medical Corporation, 682 Mendelssohn Avenue, Golden Valley, MN 55427 USA. Manufactured in U.S.A. The AMPLATZER Delivery System was designed to facilitate… |
| Recalling firm | AGA Medical Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 13, 2010 |
| PMA numbers | P000039, P020024 |
| FEI number | 3005334138 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
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