Device recall
Z-0589-2026: Option"ELITE Vena Cava Filter System REF 352506070E UDI-DI code: 00886333217151…
FDA device recall · Class II · Argon Medical Devices, Inc
Key facts
| Recall number (Z-number) | Z-0589-2026 |
|---|---|
| Recall event | 97626 |
| Product | Option"ELITE Vena Cava Filter System REF 352506070E UDI-DI code: 00886333217151 The Option"ELITE Filter is indicated for the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the inferior vena cava (IVC) in the following conditions: " Pulmonary thromboembolism when… |
| Product code | DTK |
| Recalling firm | Argon Medical Devices, Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K133243 |
| FEI number | 1625425 |
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