Device recall
Z-0081-2014: Cordis OPTEASE Vena Cava Filter Is indicated for use in the prevention of…
FDA device recall · Class II · Cordis Corporation
Key facts
| Recall number (Z-number) | Z-0081-2014 |
|---|---|
| Recall event | 66483 |
| Product | Cordis OPTEASE Vena Cava Filter Is indicated for use in the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the vena cava in the following situations: - Pulmonary thromboembolism when anticoagulants are contraindicated, - Failure of anticoagulant therapy for… |
| Product code | DTK |
| Recalling firm | Cordis Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 23, 2014 |
| 510(k) numbers | K091077 |
| FEI number | 1016427 |
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