1 — Class II medical device recall Z-2545-2016
Terminated recall by LeMaitre Vascular, Inc., reported 2016-08-24, distributed nationwide. Wire which deploys the loop may be come detached at the handle causing the device to be inoperable
| Recall number | Z-2545-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | LeMaitre Vascular, Inc., Burlington, MA, United States |
| Recall initiated | 2016-08-03 |
| Classified | 2016-08-16 |
| Reported by FDA | 2016-08-24 |
| Terminated | 2021-04-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, BR, CA, CH, CZ, DE, DK, ES, FI, FR, GB, IT, JP, NL, RU, SE |
| Quantity | 50 units |
| Reason classes | device malfunction |
| Lot numbers | 2021-03, ELVH1091V |
| Model numbers | 1010-00 |
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 for recall
Wire which deploys the loop may be come detached at the handle causing the device to be inoperable
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2545-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.