Events

Recall of Intro-Flex Automatic Hemostasis Valve Introducer

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Edwards Lifesciences 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-01488-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-12-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01488-1
  • 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
    This recall involves an introducer sheath that was found to be out of specification. if the sheath inner diameter is too small, the clinician may have difficulty inserting the dilator or catheter into the introducer. this will cause a procedural delay as the clinician will need to change out the device over a guidewire with a minimal delay in treatment.There have been no injuries as a result of this issue.
  • Action
    Edwards is advising users to inspect stock and quarantine any remaining units of the affected lot. Affected units can be returned to Edwards.

Device

Intro-Flex Automatic Hemostasis Valve Introducer
  • Model / Serial
    Intro-Flex Automatic Hemostasis Valve IntroducerModel Number: I300F85Lot Number: 60377828ARTG Number: 146688
  • Manufacturer
    Edwards Lifesciences Pty Ltd

Manufacturer

Edwards Lifesciences Pty Ltd