Events

Recall of Balt Cristal Balloons

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Pyramed 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-01483-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-12-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01483-1
  • 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
    Pyramed has identified a potential problem with the y connector detaching from the outer sheath of the device. this may result in the balloon remaining partially inflated in the patient and this may require manual and/or surgical retrieval.
  • Action
    Pyramed is advising customers to isolate affected stock from inventory. Pyramed will arrange for collection and replacement of affected devices.

Device

Balt Cristal Balloons
  • Model / Serial
    Balt Cristal BalloonsProduct Number: CBV18x40/110Batch Number: 00294780 - Expiry Date: 30/09/2022ARTG Number: 164958
  • Manufacturer
    Pyramed Pty Ltd

Manufacturer

Pyramed Pty Ltd