Events

Recall of Inspira Air Balloon Dilation System (Bronchial balloon catheter)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Johnson & Johnson Medical 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-2013-RN-00907-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-09-02
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00907-1
  • 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
    There is potential for the balloon to not deflate or deflate slowly, which could result in airway obstruction until the balloon is deflated or removed. reports of difficulty deflating the balloon during a procedure have been received. in each of these reports, difficulty deflating occurred after the surgeon had pulled against resistance in response to the balloon moving distally during dilation. the force applied to the catheter stretched and narrowed the balloon catheter shaft, causing the balloon to be difficult or impossible to deflate. the potential for this issue to occur exists in all lots and all sizes of the inspira air balloon dilation system.
  • Action
    Johnson & Johnson Medical is updating the information in the instructions for use (IFU) to include the following warnings: - Should the balloon move distally or proximally in the patient while inflated, it is not be held or pulled against. - The Inspira Air Balloon Catheter should only be placed in anatomical locations where a portion of the balloon can be continually visualised to ensure access in the unlikely event of deflation difficulty.

Device

Inspira Air Balloon Dilation System (Bronchial balloon catheter)

Manufacturer

Johnson & Johnson Medical Pty Ltd