Events

Recall of Device Recall LeMaitre Stent Guide

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by LeMaitre Vascular, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    64704
  • Event Risk Class
    Class 2
  • Event Number
    Z-1054-2013
  • Event Initiated Date
    2013-03-18
  • Event Date Posted
    2013-04-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-12-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116825
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Assembly, thigh/knee/shank/ankle/foot, external - Product Code KFX
  • Reason
    Devices were not sealed correctly during the manufacturing process, and the sterility of these products have been compromised.
  • Action
    LeMaitre sent an "URGENT:VASCUTAPE RADIOPAQUE TAPE DEVICE FIELD SAFETY NOTICE" dated March 20, 2013 to affected customers. The recall letter contains a form that requests customers to return to LeMaitre Vascular, Inc. as a record of notification and reconciliation. The letter provides instructions on how the customer can inspect the defective tape seals and/or return the affected products for replacement/credit.

Device

Device Recall LeMaitre Stent Guide
  • Model / Serial
    LSG1130, exp. 2017-04; LSG1132, exp. 2017-11
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Canada, EU, and Asia.
  • Product Description
    LeMaitre Stent Guide: 1102-00 (100 strips); 1102-50 (50 strips); 1102-20 (20 strips). || Intended to be placed on the skin to assist during imaging procedures.
  • Manufacturer
    LeMaitre Vascular, Inc.

Manufacturer

LeMaitre Vascular, Inc.
  • Manufacturer Address
    LeMaitre Vascular, Inc., 63 2nd Ave, Burlington MA 01803-4413
  • Manufacturer Parent Company (2017)
    LeMaitre Vascular, Inc.
  • Source
    USFDA