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FDAAugust 3, 2016device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

lemaitre vascularlemaitre

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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