FDA Device recall Z-2545-2016
1.5 mm HYDRO LeMaitre Valvulotome, 40 cm
- FDA Device
- Class II
- terminated
- Published 2016-08-24
On 2016-08-24 the FDA classified a Class II recall of 1.5 mm HYDRO LeMaitre Valvulotome, 40 cm by Lemaitre Vascular, citing wire which deploys the loop may be come detached at the handle causing the device to be inoperable.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2545-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-08-03 |
| Published | 2016-08-24 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Lemaitre Vascular |
| Distribution | US |
Product
1.5 mm HYDRO LeMaitre Valvulotome, 40 cm. Sterile REF # 1010-00 Product Usage: The HYDRO LeMaitre Valvulotome is intended for the treatment of vascular disorders and more particularly for excising or disrupting venous valves
Reason
Wire which deploys the loop may be come detached at the handle causing the device to be inoperable
Identifiers
| code_info | Lot Number Exp Date ELVH1089V¿ 2021-03 ELVH1091V 2021-03¿ |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2545-2016%22
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