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
    18190
  • Event Initiated Date
    2015-03-17
  • 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
    The manufacturer is updating the instructions for use to include new safety information., * it is mandatory to perform the endobag pre-fill step, * use only non-heparinised sterile saline for the endobag prer-fill step, * after aspiration of the pre-fill non-heparinised sterile sale volume, carefully inject polymer solution into the endobags under pressure monitoring.
  • Action
    Instructions for use to be updated

Device

Endologix Nellix EndoVascular Aneurysm Sealing System
  • Model / Serial
    Model: All models, Affected: All lots
  • Manufacturer
    Endologix, Inc.

Manufacturer

Endologix, Inc.