Events

Recall of Maquet demonstration unit fiber-optic Intra-Aortic Balloon Catheter

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Maquet Australia Pty 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
    RC-2015-RN-00012-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-01-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00012-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    During manufacturing of the sterile, for patient-use, sensation and sensation plus iabc products, the ferrule cap is intended to be removed from the fiber-optic connection at the time of final packaging.Maquet have identified that during the packaging of some demonstration, fiber-optic sensation and sensation plus iabc units, the ferrule cap was not removed. if the fiber-optic connector on an affected non-sterile, non-patient use, demonstration unit is inserted into patient-use maquet cs300, cardiosave intra-aortic balloon pump (iabp) or iabps upgraded with a fiber-optic module, the cap may become dislodged and remain in the fiber-optic receptacle of the pump.If a pump unit is subsequently used with a clincal use fiber optic balloon catheter inserted into the mating connector, the catheter will notmake an electrical connection with the iabp. the catheter will not be recognised as a fiber optic catheter. the system will still be able to pump as a non fiber optic balloon.
  • Action
    Maquet is providing instructions for the inspection of the demonstration units and the Intra-Aortic Balloon Pumps. End users are requested to inspect and remove the Ferrule caps if present on the pump of demonstration catheter. A Maquet technician will inspect potentially affected devices if required. This action has been closed-out on 11/08/2016.

Device

Maquet demonstration unit fiber-optic Intra-Aortic Balloon Catheter
  • Model / Serial
    Maquet demonstration unit fiber-optic Intra-Aortic Balloon Catheter ARTG Number: N/A Demonstration model only
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

Maquet Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    DHTGA