Device recall
Z-2544-2016: 1.5 mm HYDRO LeMaitre Valvulotome without LeMills, 98 cm. Sterile REF# 1009-00J…
FDA device recall · Class II · LeMaitre Vascular, Inc.
Key facts
| Recall number (Z-number) | Z-2544-2016 |
|---|---|
| Recall event | 74880 |
| Product | 1.5 mm HYDRO LeMaitre Valvulotome without LeMills, 98 cm. Sterile REF# 1009-00J Product Usage: The HYDRO LeMaitre Valvulotome is intended for the treatment of vascular disorders and more particularly for excising or disrupting venous valves |
| Product code | MGZ |
| Recalling firm | LeMaitre Vascular, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 8, 2021 |
| 510(k) numbers | K140042 |
| FEI number | 1220948 |
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