Events

Recall of H.LEE SAFESHEATH CSG (CORONARY SINUS GUIDE) HEMOSTATIC INTRODUCER SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by LIVANOVA CANADA CORP..

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
    20154
  • Event Risk Class
    II
  • Event Initiated Date
    2010-01-22
  • 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
    Thomas medical products has recently become aware that in some instances the safesheath csg (coronary sinus guide) hemostatic introducer with radiopaque/soft tip may fracture during in vivo use resulting in device fragments that will remain in the patient's vasculature.

Device

H.LEE SAFESHEATH CSG (CORONARY SINUS GUIDE) HEMOSTATIC INTRODUCER SYSTEM
  • Model / Serial
    Model Catalog: CSG/WORLEY-2-09 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: CSG/WORLEY/BCOR-2-09 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: CSG/WORLEY/BCOR-1-09 (Lot serial: >10 NUMBERS CONTACT MFR)
  • Product Description
    SAFESHEATH CSG HEMOSTATIC INTRODUCER
  • Manufacturer
    LIVANOVA CANADA CORP.

Manufacturer

LIVANOVA CANADA CORP.
  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
    LivaNova PLC
  • Source
    HC