Events

Recall of Maquet HLS Cannulae

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

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
    13564
  • Event Initiated Date
    2012-09-28
  • 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: Maquet Australia Pty Ltd (NZ), 12G Andromeda Cres East Tamaki, Auckland 2013
  • Reason
    The manufacturer advises that in rare cases it is not possible to insert the guide wire through the introducer of the hls-cannulae. the problem ocurs prior to vascular access and the cannulae itself functions properly during perfusion.
  • Action
    Product to be returned to supplier

Device

Maquet HLS Cannulae
  • Model / Serial
    Model: PVL 2155, BE-PAS-1515, BE-PAS-1715, BE-PAS-1915, BE-PAL-1723, BE-PAL-1923, BE-PVL-2155, BE-PVL-2355, BE-PVL-2555, BE-PVL-2955, Affected: 23 lots
  • Manufacturer
    Maquet Cardiopulmonary AG

Manufacturer

Maquet Cardiopulmonary AG
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    NZMMDSA