Events

Recall of Vascutek Thoraflex Hybrid Device

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

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
    17011
  • Event Initiated Date
    2014-07-16
  • 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
    Manufacturer provides a high temperature cautery with each gelweave and thoraflex hybrid product and a low temperature cautery with each biovalsalva stentless biplex , stented biovalsalva biplex and rvot elan biplex conduit. these cauteries are used to cut and trim the graft. manufacturer has decided to stop supplying the cautery with these product packs due to the cautery battery having a shorter shelf life than the vascutek graft product. manufacturer will update the ifu, removing the reference to the inclusion of a catery with thes products., manufacturer will not be recalling any product as there is negligible rsk to users and patients.
  • Action
    Instructions for use to be updated

Device

Vascutek Thoraflex Hybrid Device
  • Model / Serial
    Model: , Affected: all lots
  • Manufacturer
    Vascutek Ltd

Manufacturer

Vascutek Ltd