Events

Recall of HYDRO LeMaitre Valvulotome Devices (intended for the treatment of vascular disorders and particularly for excising or disrupting venous valves)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Emergo Asia Pacific Pty Ltd T/a Emergo Australia.

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-00232-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-02-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00232-1
  • 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 manufacturer, lemaitre vascular is extending the scope of the recall of hydro lemaitre valvulotome devices undertaken in august 2016 (tga ref.: rc-2016-rn-01046-1). the centering hoops keep the head of the hydro lemaitre valvulotome centered in the vessel and prevents the valve-cutting blades from damaging the vessel wall. there have been reported issues of hoops failing to close when the device was actuated. in some cases, this issue has been discovered in-use and has led to vessel damage. if the blades are stuck in the open position, the device must be removed in the open state. the removal of the device without sheathing may cause damage to the vein either during use or when the blades pass the opening of the vessel.
  • Action
    Emergo is advising customers to immediately quarantine and return unused devices from the affected lots. Returned devices will be replaced with unaffected devices.

Device

HYDRO LeMaitre Valvulotome Devices (intended for the treatment of vascular disorders and particul...
  • Model / Serial
    HYDRO LeMaitre Valvulotome Devices (intended for the treatment of vascular disorders and particularly for excising or disrupting venous valves)Catalogue number: 1009-00Lot number: ELVH1103VExpiry date : 2021-06Catalogue Number: 1010-00Lot number: ELVH1112VExpiry date : 2021-07ARTG number: 218706
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia