Events

Recall of Endologix Nellix Endovascular Aneurysm Sealing System

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand 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
    20039
  • Event Initiated Date
    2016-04-19
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: eVas Medical, 73 Churchill Road, Murrays Bay, Auckland 0630
  • Reason
    Updated instructions for use (ifu) for the nellix endovascular aneurysm sealing system., feature that differentiates nellix from other aaa endovascular devices is the use of a 2-part water soluble polymer that is used to fill the aneurysmal space. during the nellix procedure, polymer is dispensed through fill tubes within the catheter into endobags which surround the stent grafts. the polymer is introduced in a liquid form and begins to crosslink as soon as the components are mixed. complete crosslinking occurs inside the endobags 3 to 5 minutes after filling has been completed. the polymer will not crosslink in the fill tubes, as long as there is, continuous flow of the solution. once the polymer stops moving through the fill tubes, crosslinking can occur in 30 seconds within the fill tubes. if the polymer cures in the fill tubes, it can impede further introduction of polymer.Utilization of the secondary fill option (outline din ifu) is necessary to safely compete the filling process.
  • Action
    Instructions for use to be updated

Device

Endologix Nellix Endovascular Aneurysm Sealing System
  • Model / Serial
    Model: N10-100, N10-110, N10-120, N10-130, N10-140, N10-150, N10-160, N10-170,, Affected:
  • Manufacturer
    Endologix, Inc.

Manufacturer

Endologix, Inc.