Device recall
Z-0445-2011: Lumen Biomedical Xtract Aspiration Catheter system, intravascular catheter…
FDA device recall · Class II · Volcano Corporation
Key facts
| Recall number (Z-number) | Z-0445-2011 |
|---|---|
| Recall event | 57282 |
| Product | Lumen Biomedical Xtract Aspiration Catheter system, intravascular catheter, consisting of One Catheter, Two 30 mL Syringes, One Extension Tube with Stopcock, and One 40 um Cell Strainer. Single-user, 0.014" guidewire compatible intravascular extraction and aspiration catheter, Part number 1450-0001… |
| Product code | OGX |
| Recalling firm | Volcano Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 7, 2011 |
| 510(k) numbers | K071529 |
| FEI number | 2939520 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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