| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00242-1 |
| Product Name/Description |
Danis Procedure Pack and Danis Procedure Pack - Basic
Product Reference Numbers: 019-08S-25-135 and 019-08S-25-135-B
Lot Numbers: P14080073-01, P15020247-01, P15030171-01, P15110018-01, P15100210-01 and P17010044-01
ARTG Number: 95573 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
8/03/2017 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer ELLA-CS has identified an unintended positioning of the safety valve of the fixation- gastric balloon of the delivery system in the Danis Procedure Pack. This issue will cause the surgeon to not be able to insufflate the fixation – gastric balloon and hence, be unable to correctly place the delivery system. As such, the surgeon will to have to stop the acute oesophageal variceal bleeding using another Danis stent, or other methods, which may prolong the procedure and bleeding. This extension of the procedure may cause deterioration of the patient’s condition and health. At this stage, the manufacturer is not aware of any reported injury connected with this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Endotherapeutics is advising surgeons to check the position of the safety valve. If the safety valve does not cover the opening designed for spontaneous deflation of the fixation – gastric balloon, to return it to the appropriate position to allow performance of the stent implantation with fixation of the delivery system in the cardia. Surgeons are further advised that if the safety valve does not cover the opening for spontaneous deflation of the fixation – gastric balloon and it is not returned to the appropriate position, the Danis stent can be introduced by conventional techniques for the implantation of oesophageal stents.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG |
| Contact Information |
02 9869 2868 - Endotherapeutics |