Events

Safety Alert for AFX Introducer System

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

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
    2013-06-19
  • Event Date Posted
    2013-06-19
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130619.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: endologix afx introducer system the united states food and drug administration (fda) has issued a medical device safety alert concerning afx introducer system [model. no.: s17-45; lot no.: 1079840, 1079843, 1079844, 1079845], manufactured by endologix inc. according to the fda, the afx introducer system is intended to help introduce catheters and other medical devices into blood vessels during procedures with minimal blood loss. this product was recalled due to reports of the dilator breaking during procedures. use of this recalled product may cause serious adverse health consequences, including death. for details, please visit the following fda websites: http://www.Fda.Gov/safety/medwatch/safetyinformation/ safetyalertsforhumanmedicalproducts/ucm357563.Htm http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm357544.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 19 june 2013.

Device

AFX Introducer System

Manufacturer

Endologix Inc