Events

Recall of LEMAITRE OVER-THE-WIRE CATHETER

According to Health Canada (via FOI), this recall involved a device in Canada 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
    41407
  • Event Risk Class
    II
  • Event Initiated Date
    2015-11-02
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    A manufacturing issue could cause a pinhole in the formed end of the packaging tubes for this device and the sterility of these products could be compromised.

Device

LEMAITRE OVER-THE-WIRE CATHETER
  • Model / Serial
    Model Catalog: E1651-78 (Lot serial: L/N OTW3046 EXP: 2021-02); Model Catalog: 1651-88 (Lot serial: L/N OTW3046 EXP: 2021-02); Model Catalog: E1651-78 (Lot serial: L/N OTW3113 EXP: 2021-06); Model Catalog: 1651-88 (Lot serial: L/N OTW3113 EXP: 2021-06)
  • Product Description
    LeMaitre Over-The-Wire Catheter
  • Manufacturer
    LEMAITRE VASCULAR INC.

Manufacturer

LEMAITRE VASCULAR INC.