Events

Recall of BARD LUMINEXX 3 VASCULAR STENT - 60 CM DELIVERY SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BARD CANADA 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
    76631
  • Event Risk Class
    II
  • Event Initiated Date
    2005-07-22
  • 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 consistent increase in the internal scrap rate (failure mode: broken stent struts) of nitinol stents was observed.

Device

BARD LUMINEXX 3 VASCULAR STENT - 60 CM DELIVERY SYSTEM
  • Model / Serial
    Model Catalog: LUD10040 (Lot serial: 96DP0932 96DP1701 96DP1702); Model Catalog: LUD09060 (Lot serial: 96DP0932 96DP1701 96DP1702); Model Catalog: LUD08030 (Lot serial: 96DP0932 96DP1701 96DP1702); Model Catalog: LUD09060 (Lot serial: 96DP2080); Model Catalog: LUD09040 (Lot serial: 96DP2080); Model Catalog: LUD12100 (Lot serial: 96DP0932 96DP1701 96DP1702); Model Catalog: LUD09040 (Lot serial: 96DP0932 96DP1701 96DP1702); Model Catalog: LUD06030 (Lot serial: 96DP0932 96DP1701 96DP1702); Model Catalog: LUD06030 (Lot serial: 96DP2080); Model Catalog: LUD09080 (Lot serial: 96DP2080); Model Catalog: LUD10080 (Lot serial: 96DP2080); Model Catalog: LUD08060 (Lot serial: 96DP0932 96DP1701 96DP1702); Model Catalog: LUD08030 (Lot serial: 96DP2080); Model Catalog: LUD12100 (Lot serial: 96DP2080); Model Catalog: LUD10040 (Lot serial: 96DP2080); Model Catalog: LUD08060 (Lot serial: 96DP2080); Model Catalog: LUD10080 (Lot serial: 96CP2026 96CP2531 96EP0861); Model Catalog: LUD09080 (Lot serial: 96CP2026 96CP2531 96EP0861
  • Product Description
    BARD LUMINEXX 3 VASCULAR STENT
  • Manufacturer
    BARD CANADA INC.

Manufacturer

BARD CANADA INC.