| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00990-1 |
| Product Name/Description |
EndoBarrier Gastrointestinal Liner System
Part Number: 40-10-00624
ARTG Number: 186462 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
12/10/2015 |
| Responsible Entity |
|
| Reason/Issue |
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. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
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. |
| Contact Information |
02 9006 1662 - Emergo |