Events

Safety Alert for EMBOL-X Glide Protection System

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Edwards Lifesciences Ltd.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2013-10-02
  • Event Date Posted
    2013-10-02
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131002c.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: edwards lifesciences embol-x glide protection system the medicines and healthcare products regulatory agency (mhra), united kingdom (uk) posted a medical device safety alert concerning embol-x glide protection system manufactured by edwards lifesciences ltd. the affected model numbers are exgf24, exgf24ll, exgf24mm, exgf24ss, exgf24xl, exgf24xs. through a complaint investigation, edwards lifesciences has identified a potential health risk to patients undergoing cardio pulmonary by-pass surgery when using the embol-x glide protection system. the reported complaint involved a deformed tip of the cannula that is part of the embol-x glide protection system, this was confirmed during product evaluation. as a result, the manufacturer is recalling all lot numbers of the embol-x glide protection system cannulae that have not expired. no patient injury was reported with the use of this device. the manufacturer believes that risk of injury to patients from this issue is possible; if the defect is not noticed during preparation, when force applied to the tip during insertion or removal, it may lead to a separation and embolize. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con316301 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 2 october 2013.

Device

EMBOL-X Glide Protection System

Manufacturer

Edwards Lifesciences Ltd