LeMaitre Vascular, Inc.: Medical Device Recall in 2016 - (Recall #: Z-2543-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: August 3, 2016

Date Posted: August 24, 2016

Recall Number: Z-2543-2016

Event ID: 74880

Reason for Recall:

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

Status: Terminated

Product Quantity: 1992 units

Code Information:

Lot Number Exp Date ELVH1072V 2020-07 ELVH1082V 2021-01 ELVH1083V 2021-01 ELVH1084V 2021-02 ELVH1085V 2021-02 ELVH1086V 2021-02 ELVH1087V 2021-02 ELVH1088V 2021-03

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated