Events

Recall of PERCUTANEOUS SHEATH INTRODUCER KIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by EDWARDS LIFESCIENCES (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
    33908
  • Event Risk Class
    II
  • Event Initiated Date
    2009-05-26
  • 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
    Blue connector proximal to touhy-borst hemostasis valve may fatigue crack or separate resulting in patency failure & potential blood loss where intro-flex introducer secures a venous catheter.

Device

PERCUTANEOUS SHEATH INTRODUCER KIT
  • Model / Serial
    Model Catalog: I652BF85H (Lot serial: 58511631 58549300 58606253); Model Catalog: S5507BF85 (Lot serial: 58648812 58496258 58535112); Model Catalog: I652BF85H (Lot serial: 58648812 58496258 58535112); Model Catalog: S5507BF85 (Lot serial: 58604814 58644423); Model Catalog: S5507BF85 (Lot serial: 58511631 58549300 58606253); Model Catalog: I652BF85H (Lot serial: 58604814 58644423); Model Catalog: 1350BF85 (Lot serial: MANUFACTURER); Model Catalog: 1350BF85 (Lot serial: >10 NUMBERS); Model Catalog: 1350BF85 (Lot serial: CONTACT)
  • Product Description
    PERCUTANEOUS SHEATH INTRODUCER KIT
  • Manufacturer
    EDWARDS LIFESCIENCES (CANADA) INC.

Manufacturer

EDWARDS LIFESCIENCES (CANADA) INC.