LeMaitre Vascular, Inc. recalls 1.5 mm HYDRO LeMaitre Valvulotome without LeMills, 98 cm. Sterile REF# 1009-00J Product Usage: The HYDRO LeMaitre Valvu…

Recall date

August 3, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2544-2016

FDA classification

Class II

Brand / firm

LeMaitre Vascular, Inc.

Sold / distributed

Worldwide Distribution -  US Nationwide and in the countries of Australia, BELGIUM, BRAZIL, CANADA, Czech Republic, DENMARK, FINLAND, FRANCE, GERMANY, Italy, Japan, NETHERLANDS, Russia, Spain, SWEDEN, Switzerland, and UK.

Why it was recalled

Wire which deploys the loop may be come detached at the handle causing the device to be inoperable

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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