Events

Recall of EV3 Onyx Liquid Embolic Systems

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by ev3 Neurovascular.

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
    13088
  • Event Initiated Date
    2012-08-01
  • 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: Lifehealthcare Ltd New Zealand, Unit E 61 Hugo Johnston Drive, Penrose, Auckland 1642
  • Reason
    Fda notified physicians and patients about the risk of catheter entrapment associated with the use of onyx. catheter entrapment happens when the catheter becomes stuck in the implanted onyx material. the most serious complications include hemorrhage and death. other complications include migration of the onyx plug or catheter fragment to other parts of the body. patients with catheter entrapment may need to take antithrombotic drugs to prevent blood clots around the catheter, and may need to undergo one or more imaging procedures to locate a piece of the catheter and onyx plug, increasing their exposure to radiation.
  • Action
    Instructions for use to be updated

Device

EV3 Onyx Liquid Embolic Systems
  • Model / Serial
    Model: All models, Affected: All lots
  • Manufacturer
    ev3 Neurovascular

Manufacturer

ev3 Neurovascular
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    NZMMDSA