Events

Recall of Device Recall System, Endovascular Graft Aortic Aneurysm Treatment

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Endologix 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
    36803
  • Event Risk Class
    Class 2
  • Event Number
    Z-0309-2007
  • Event Initiated Date
    2006-11-08
  • Event Date Posted
    2006-12-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-11-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49382
  • 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
    endovascular graft - Product Code MIH
  • Reason
    Recall was initiated after a clinical incident involving separation of the front sheath, preventing deployment of the stent graft. this required the physician to convert the patient to conventional open repair.
  • Action
    The affected hospitals were contacted telephone on 11/08/06 and in writing (Recall Letters) sent via FedEx 11/09/06. The firm also released a press statement on 11/10/06. All affected consignees have been contacted and instructed to return the specified products to Endologix.

Device

Device Recall System, Endovascular Graft Aortic Aneurysm Treatment
  • Model / Serial
    Lot Numbers: W06-0333, W06-0392, W06-0500, W06-0553, W06-0621, W06-1100 & W06-1152
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide, including USA and Germany.
  • Product Description
    Endologix Infrarenal Bifurcated Powerlink System with Visifiex Delivery System (endovascular graft). Model Number 25-16-155BL
  • Manufacturer
    Endologix Inc

Manufacturer

Endologix Inc
  • Manufacturer Address
    Endologix Inc, 11 Studebaker, Irvine CA 92618-2013
  • Source
    USFDA