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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 LeMaitre see related information
Date Initiated by Firm August 03, 2016
Create Date August 16, 2016
Recall Status1 Terminated 3 on April 08, 2021
Recall Number Z-2544-2016
Recall Event ID 74880
510(K)Number K140042  
Product Classification Valvulotome - Product Code MGZ
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
Code Information Lot Number Exp Date ELVH1078V¿ 2020-10 ELVH1079VA 2020-10
Recalling Firm/
Manufacturer		 LeMaitre Vascular, Inc.
63 2nd Ave
Burlington MA 01803-4413
For Additional Information Contact SAME
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
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.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = MGZ and Original Applicant = LEMAITRE VASCULAR, INC.
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