Events

Recall of LeMaitre Single Lumen Embolectomy Catheter 3F, 80 cm

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-2015-RN-01089-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-11-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01089-1
  • 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
    Lemaitre embolectomy catheters are indicated for the removal of arterial emboli and thrombi. a small number of these products from the affected lot may have a compromised sterile barrier due to a packaging tube defect in the form of a pinhole at the sealed end of the packaging tube. the current ifu does not require inspection of the packaging prior to use and loss of product sterility could not be visually identified. the issue occurred due to fluctuations in the power sources for the sealing machine during the packaging tube manufacturing process.Loss of product sterility could lead to cross-contamination and infection.No complaints have been received relating to this issue.
  • Action
    Users are asked to inspect their stock and quarantine all affected units prior to their return to Emergo as per the instructions in the Customer Letter. This action has been closed-out on 18/08/2016.

Device

LeMaitre Single Lumen Embolectomy Catheter 3F, 80 cm

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia