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U.S. Department of Health and Human Services

Class 2 Device Recall LeMaitre

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 Class 2 Device Recall LeMaitresee related information
Date Initiated by FirmAugust 03, 2016
Create DateAugust 16, 2016
Recall Status1 Terminated 3 on April 08, 2021
Recall NumberZ-2545-2016
Recall Event ID 74880
510(K)NumberK140042 
Product Classification Valvulotome - Product Code MGZ
Product1.5 mm HYDRO LeMaitre Valvulotome, 40 cm. Sterile REF # 1010-00 Product Usage: The HYDRO LeMaitre Valvulotome is intended for the treatment of vascular disorders and more particularly for excising or disrupting venous valves
Code Information Lot Number Exp Date ELVH1089V¿ 2021-03 ELVH1091V 2021-03¿ 
Recalling Firm/
Manufacturer		 LeMaitre Vascular, Inc.
63 2nd Ave
Burlington MA 01803-4413
For Additional Information ContactSAME
781-221-2266
Manufacturer Reason
for Recall		Wire which deploys the loop may be come detached at the handle causing the device to be inoperable
FDA Determined
Cause 2		Process control
ActionLeMaitre 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 Commerce50 units
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = MGZ
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