Z-2544-2016Class II

1.5 mm HYDRO LeMaitre Valvulotome without LeMills, 98 cm. Sterile REF# 1009-00J

Name: Z-2544-2016 1.5 mm HYDRO LeMaitre Valvulotome without LeMills, 98 cm. Sterile REF# 1009-00J
Creator: LeMaitre Vascular, Inc.
Published: 2016-08-03
License: https://open.fda.gov/license/

LeMaitre Vascular Inc. / initiated 2016-08-03 / Terminated / root cause: manufacturing process

FDA source

LeMaitre Vascular, Inc. began a recall of 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... on 2016-08-03. FDA classified it as Class II and gives the reason as "Wire which deploys the loop may be come detached at the handle causing the device to be inoperable". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2544-2016
Classification: Class II
Status: Terminated
Initiated: 2016-08-03
Posted: 2016-08-16
Terminated: 2021-04-08
Recalling firm: LeMaitre Vascular Inc.
Product: 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
Product code: MGZ Valvulotome
Reason for recall: Wire which deploys the loop may be come detached at the handle causing the device to be inoperable
Root cause tag: manufacturing process
FDA root cause: Process control
Action: LeMaitre Vascular, Inc. sent an Urgent Medical Device Recall letter dated June 29, 2016 to customers via priority mail. The letter identified the affected product, problem and actions to be taken. Customers were requested to locate, quarantine and return the devices. Customers were instructed to complete and return the response form to LeMaitre Vascular, Inc. as a record of notification and reconciliation. Any unused product will be requested to be returned and replaced. For questions call 781-221-2266 ext. 183.
Quantity in commerce: 380 units
Distribution: 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.
Product codes and lots: Lot Number Exp Date ELVH1078V¿ 2020-10 ELVH1079VA 2020-10

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2544-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2543-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-24	2016-08-16
Z-2544-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-24	2016-08-16
Z-2545-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-24	2016-08-16

Product code MGZ

K140042Class II1.5Mm Hydro Expandable Lemaitre ValvulotomeLeMaitre Vascular, Inc. / cleared 2014-04-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)