Events

Recall of Terumo Advanced Perfusion System 1

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Terumo Cardiovascular Systems 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
    20499
  • Event Initiated Date
    2016-08-15
  • 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: Terumo Australia Pty Ltd (NZ), c/- Healthcare Logistics, 56 Carrington Road, Mount Albert, Auckland 1025
  • Reason
    Reports have been received of issues that manifest themselves as power or communications failures in the system network. terumo's investigation revealed an internal cable with an inadequate crimp was installed in a subset of the total population of terumo system 1 units. the poor crimp in the cable can create a loss or degradation of internal power on one side of the system's base.
  • Action
    Instructions for use to be updated

Device

Terumo Advanced Perfusion System 1

Manufacturer

Terumo Cardiovascular Systems Inc