Events

Recall of Bard Inlay Optima Ureteral Stents InLay Optima Multi-length Ureteral Stent with NiCoreNitinol/Nitinol Guidewire, InLay Optima Multi-length Ureteral Stent with HydroGlide Guidewire, InLay Optima Multi-length Ureteral Stent without Guidewire

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Bard Australia 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-2016-RN-01369-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-10-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01369-1
  • 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
    The food and drug administration (fda) has requested manufacturers of multi-length ureteral stents to add a statement in the warnings/precautions section of product labelling, requesting end users to consider the presence of a knot if significant resistance is encountered during attempts at removal. bard has completed an internal assessment and concluded that there is the potential for a moderate severity of harm to a patient should the medical professional fail to consider the formation of a knot if significant resistance is encountered during attempts at removal. bard is including additional warning/precaution for all of bard’s multi-length ureteral stents.
  • Action
    Bard is including additional warning/precaution for all of Bard’s multi-length ureteral stents: Formation of knots in multi-length ureteral stents may occur. This may result in injury to the ureter during removal and/or the need for additional surgical intervention. The presence of a knot should be considered if significant resistance is encounter during attempts at removal. Users are advised to follow the above warning/precaution for the stock they currently hold. Any stock purchased after November 15, 2016 is expected to have the above warning/precaution statement in the labelling. This action has been closed-out on 18/05/2017.

Device

Bard Inlay Optima Ureteral Stents InLay Optima Multi-length Ureteral Stent with NiCoreNitinol/Nit...
  • Model / Serial
    Bard Inlay Optima Ureteral StentsInLay Optima Multi-length Ureteral Stent with NiCoreNitinol/Nitinol GuidewireProduct Codes: 786400, 786600, 786700, 786800InLay Optima Multi-length Ureteral Stent with HydroGlide GuidewireProduct Codes: 787400, 787600, 787700, 787800InLay Optima Multi-length Ureteral Stent without GuidewireProduct Codes: 788400, 788600, 788700, 788800ARTG Number: 235658
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd