Events

Recall of EndoBarrier Gastrointestinal Liner System

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-00990-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-10-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00990-1
  • 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 hazard alert notification is intended to ensure that an appropriate communication is made to all customers regarding early termination of the endo trial investigational device exemption (ide) study in the united states (u.S.) and a change in rate of hepatic abscess observed globally.Due to the incidence rate of hepatic abscess (ha) in the u.S. ide endo trial exceeding the established safety threshold of 2%, the study was terminated by gi dynamics prior to completion.This notice serves to remind users of the signs of ha and request that clinicians raise the awareness of the clinical symptoms and signs of ha in their patients as early detection will reduce the severity and sequelae of ha should it arise.Please continue to educate patients on the early signs of ha (e.G., right upper quadrant pain, abdominal pain, fever/chills/malaise) and remind them to seek medical attention for immediate treatment and resolution to mitigate any complications should they be present.
  • Action
    This notice serves to remind all users of the signs of HA and to request that clinicians raise the awareness of the clinical symptoms and signs of HA in their patients as early detection will reduce the severity and sequelae of HA should it arise. Please continue to educate patients on the early signs of HA (e.g., right upper quadrant pain, abdominal pain, fever/chills/malaise) and remind them to seek medical attention for immediate treatment and resolution to mitigate any complications should they be present. Report all adverse incident cases of HA to both GI Dynamics and the TGA. For further infromation, please see http://www.tga.gov.au/alert/endobarrier-duodenal-jejunal-bypass-liner-delivery-system . This action has been closed-out on 19/08/2016.

Device

EndoBarrier Gastrointestinal Liner System

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia