Events

Recall of Sinus-SuperFlex-635 Self-expanding Nitinol Stent System

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-2015-RN-00701-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-08-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00701-1
  • 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
    An investigation of field complaints indicates an increased number of deployment issues. non-deployments were reported as well partial deployments of the stent. partially deployed stents may require additional intervention by a doctor due to stent elongation or fracture.This does not affect any patients with an implanted stent of this length since the problem may only occur during the implantation of the stent.
  • Action
    Customers are advised to remove all affected products from their inventory and quarantine them in a separate area for collection by Pyramed Pty Ltd. This action has been closed-out on 18/02/2016.

Device

Sinus-SuperFlex-635 Self-expanding Nitinol Stent System
  • Model / Serial
    Sinus-SuperFlex-635 Self-expanding Nitinol Stent SystemModel numbers: 8606-6200 and 8607-6200Lot Numbers: Q009591, Q009592, Q008259, Q010150 and Q015955ARTG Number: 178915
  • Manufacturer
    Pyramed Pty Ltd

Manufacturer

Pyramed Pty Ltd