Device recall
Z-0616-04: ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and…
FDA device recall · Class II · ev3, Inc.
Key facts
| Recall number (Z-number) | Z-0616-04 |
|---|---|
| Recall event | 28210 |
| Product | ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System 7mm x 18mm 80 cm .018" REF PMP 8-7-18-80 |
| Product code | FGE |
| Recalling firm | ev3, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 8, 2005 |
| 510(k) numbers | K033134 |
| FEI number | 2183870 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 Products in the same recall event
- 100–999 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