| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01320-1 |
| Product Name/Description |
EndoBarrier Gastrointestinal Liner with Delivery System
ARTG Number: 186462 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
18/12/2014 |
| Responsible Entity |
|
| Reason/Issue |
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. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
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 . |
| Contact Information |
02 9006 1662 - Emergo Australia |