Recall of H.LEE SAFESHEATH LVI (LATERAL VEIN INTRODUCER) SHEATH

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MERIT MEDICAL SYSTEMS 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
    19518
  • Event Risk Class
    I
  • Event Initiated Date
    2011-11-17
  • Event Country
  • 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
    The radiopaque segment may detach during in vivo use resulting in device fragments that will remain in the patient's vasculature.

Device

  • Model / Serial
    Model Catalog: LVI/75-5-62-07-RE (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: LVI/TELE/B-60-07-MP (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: LVI/TELE/B-60-07-RE (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: LVI/75-5-62-07-HS (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: LVI/75-5-62-07-MP (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: LVI/TELE/B-60-07-HO (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: CSG/WORLEY/BCOR-2-09 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: CSG/WORLEY/L/BCOR-1-09 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: CSG/WORLEY/BCOR-1-09 (Lot serial: >10 NUMBERS CONTACT MFR)
  • Product Classification
  • Product Description
    SAFESHEATH LATERAL VEIN INTRODUCER
  • Manufacturer

Manufacturer