Events

Recall of Copernic2L and Eclipse2L Occlusion Balloon Catheters

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Getz Healthcare 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-2017-RN-01311-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-10-31
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01311-1
  • 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
    Getz healthcare is advising that damages on the catheters' tubes have been observed during post-marketing surveillance program. this may lead to unusual balloon behaviour during the contrast liquid injection through the guiding catheter, such as unexpected inflation and/or difficult deflation.The manufacturer, balt extrusion has received 3 reports of cases involving this issue, but there have been no reports of patient injury due to these types of failures on the devices. however, these kinds of incidents may lead to patient injury with vascular trauma if the devices are not used in accordance with the recommendations.
  • Action
    Getz Healthcare is advising users to not insert the double lumen catheters ECLIPSE2L and COPERNIC2L through the Y­ connector's side-arm; they shall be inserted through the axial-arm to prevent any deterioration of the tube. The Instructions for Use will be updated as a permanent measure.

Device

Copernic2L and Eclipse2L Occlusion Balloon Catheters
  • Model / Serial
    Copernic2L and Eclipse2L Occlusion Balloon CathetersAll Lot NumbersARTG Numbers: 263592 (Getz Healthcare Pty Ltd - COPERNIC 2L occlusion balloon catheter - Catheter, intravascular, occluding) and;263593 (Getz Healthcare Pty Ltd - ECLIPSE 2L occlusion balloon catheter - Catheter, intravascular, occluding)
  • Manufacturer
    Getz Healthcare Pty Ltd

Manufacturer

Getz Healthcare Pty Ltd