Events

Recall of Figulla Flex II ASD, Figulla Flex II PFO and Occlutech PDA Occluder Cardiac Occluders

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-00147-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-02-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00147-1
  • 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
    Occlutech has received a report whereby a customer inadvertently used an expired occlutech flex ii pusher cable and noticed doing so shortly after the implantation procedure. there was no impact on the patient, the procedure or the product performance. occlutech occluders and compatible pusher cables are packaged together into an occlutech product set which also contains the instructions for use and the patient information card. the outer label on the occlutech product set clearly shows the expiration dates of both the occluder and the pusher cable. as these dates can differ from each other, it is important to check both dates to not miss the shortest expiration date.
  • Action
    Occlutech will in future be implementing a revised Occlutech product set label showing only the shortest expiry date. For current inventory, Getz Healthcare is advising customers to immediately check the expiration dates of the Occlutech Occluder and of the pusher cable as printed on the outer box-label of all products in their current inventory. If one of the expiration dates is exceeded, customers are to block and remove the Occlutech Occluder set containing the expired product from their inventory. Getz will replace all expired stock. End-users are also advised to carefully routinely review the Occutech Occluder set labels prior to use, in accordance the Instructions for Use. This action has been closed-out on 01/03/2018.

Device

Figulla Flex II ASD, Figulla Flex II PFO and Occlutech PDA Occluder Cardiac Occluders
  • Model / Serial
    Figulla Flex II ASD, Figulla Flex II PFO and Occlutech PDA Occluder Cardiac OccludersFigulla Flex II ASDProduct Code: 29ASDxx Figulla Flex II PFOProduct Code: 19PFOxxD Occlutech PDA OccluderProduct Codes: 42PDAxx, 42PDAxxL, 43PDAxxLMultiple Lot NumbersARTG Numbers: 201602, 201603, 219523
  • Manufacturer
    Getz Healthcare Pty Ltd

Manufacturer

Getz Healthcare Pty Ltd