Device recall
Z-0389-2016: LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 6F, 80 cm, Model…
FDA device recall · Class II · LeMaitre Vascular, Inc.
Key facts
| Recall number (Z-number) | Z-0389-2016 |
|---|---|
| Recall event | 72534 |
| Product | LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 6F, 80 cm, Model 1601-68. Indicated for the removal of arterial emboli and thrombi. |
| Product code | DXE |
| Recalling firm | LeMaitre Vascular, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 12, 2019 |
| 510(k) numbers | K992368 |
| FEI number | 1220948 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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