Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2543-2016 — 1.5 mm HYDRO LeMaitre Valvulotome, 98 cm, Sterile REF # 1009-00 Product Usage: The HYDRO LeMaitre Valvulotome is intended for the treatment of vascular disorders and more particularly for excising or disrupting venous valves

U.S. FDA — Device Enforcement · United States · 2016-08-03 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2543-2016
Date of alert
2016-08-03
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
LeMaitre Vascular, Inc.
Product category
device
Product type
Devices
Reported risk: Wire which deploys the loop may be come detached at the handle causing the device to be inoperable
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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