Events

Recall of Cook Zenith Alpha™ Thoracic Endovascular Graft

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by William Cook Europe ApS.

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
    18087
  • Event Initiated Date
    2015-02-12
  • 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: Obex Medical Ltd, 303 Manukau Road, Epsom, AUCKLAND
  • Reason
    The instructions for use supplied with the device are being updated in response to recent findings of distal type i endoleak, migration and aneurysm growth during on-going longer-term follow-up of patients enrolled in the multi-national clinical investigation of the device. to date, no similar events have been reported from markets in which the device is commercially available. these findings from the clinical investigation were found to be associated with thoracic aneurysms (not ulcers) treated with a single proximal component that resulted in a short distal seal length (i.E., less than 20 mm) and likely inadequate (i.E., less than 10%) distal oversizing for the device.
  • Action
    Instructions for use to be updated

Device

Cook Zenith Alpha™ Thoracic Endovascular Graft

Manufacturer

William Cook Europe ApS