Events

Recall of Device Recall AFX Endovascular AAA System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Endologix.

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
    76112
  • Event Risk Class
    Class 2
  • Event Number
    Z-1047-2017
  • Event Initiated Date
    2016-12-27
  • Event Date Posted
    2017-01-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152175
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, endovascular graft, aortic aneurysm treatment - Product Code MIH
  • Reason
    Endologix updated the instructions for use (ifu) and implemented modifications to the afx endovascular aaa system (afx system).
  • Action
    On 6/2/15, a Dear Physician letter was sent to inform their customers of the 2014 Clinical Update on the Endologix Endovascular Systems for AAA Repair. The letter provided update reports of the cumulative clinical data and information on the Powerlink System and the AFX Endovascular AAA System (AFX System). On January 2016, a Dear Physician letter was sent to customers to inform them of the 2015 Clinical Update covering the Endologix Endovascular Systems for AAA Repair. The letter provided update reports of the cumulative clinical data and commercial experience (i.e., post-market surveillance) of the Powerlink System and the AFX Endovascular AAA system and contains important information and recommendations regarding the continued safe and effective use of these devices. On 12/27/16, a Dear Physician letter will be sent to customers to inform them of the important information related to the AFX Endovascular AAA System (AFX System). The letter provides a series of updates to the Instructions for Use (IFU) and modifications to the product were implemented, including introduction of a graft material processing improvement known as Duraply. Customer are informed of the on-going Endologix investigation that the changes may help prevent the occurrence of Type III endoleaks reported with the AFX device.

Device

Device Recall AFX Endovascular AAA System
  • Model / Serial
    The correction is not lot specific. It applies to AFX procedures conducted after October 2015
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    US and worldwide: Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Israel, Italy, Latvia, Luxembourg, Monaco, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland, Turkey, United Kingdom.
  • Product Description
    AFX Endovascular AAA System, Endoleak Type IIIA || Product Usage: || The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).
  • Manufacturer
    Endologix

Manufacturer

Endologix
  • Manufacturer Address
    Endologix, 35 Hammond, Irvine CA 92618-1607
  • Manufacturer Parent Company (2017)
    Endologix Inc.
  • Source
    USFDA