Events

Recall of EndoBarrier Gastrointestinal Liner with Delivery 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-2014-RN-01320-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-12-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01320-1
  • 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
    Following the assessment of the risk/benefit profile during audit by the notified body, sgs, a review of the company’s historical clinical evidence for the endobarrier has been undertaken. resulting from this review gi dynamics is updating the endobarrier’s indications for use, contraindications and possible adverse events to ensure adequate risk mitigation. the change in indication specifically aims to reflect that the obesity indication includes a restriction to patients with a body mass index (bmi) = 30 kg/m2.
  • Action
    Emergo is notifying their customers of the additional warnings, contraindications and limitations to the indications. Surgeons are advised that any patients implanted with the device contrary to the additional safety information should be monitored closely for the potential complications and adverse events. The decision to remove the EndoBarrier Gastrointestinal Liner System should take into consideration the patients clinical history in the context of the new information in the IFU. This action has been closed-out on 03/05/2016. For additional information see http://tga.gov.au/alert/endobarrier-gastrointestinal-liner-delivery-system .

Device

EndoBarrier Gastrointestinal Liner with Delivery System

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia