| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2021-RN-01421-1 |
| Product Name/Description |
Endurant II/IIs Stent Graft System Radiopaque (RO) Marker Bond Detachment
Item Code: ESBF3614C103EE
Lot Number: V29781951
All products manufactured before 11-JUL-2020.
ARTG 235711
(Medtronic Australasia Pty Ltd - Endurant IIs Stent Graft System - Abdominal aortic aneurysm stent) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
23/06/2021 |
| Responsible Entity |
|
| Reason/Issue |
Medtronic has identified that this specific subset of Endurant II/IIs Stent Graft Systems may have a higher potential of radiopaque (RO) marker bond detachment during stent graft deployment.
Since the RO marker bond detachment occurs during stent graft deployment and impacts the delivery system, there are no additional actions required for patients where the Endurant II/IIs Stent Graft Systems was successfully deployed during a procedure.
As of 09-JUN-2021, Medtronic has received two (2) product complaints related to RO marker bond detachment in this subset of devices. In each of the two cases, the patient was converted to open repair and died during the open procedure. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are advised to identify, quarantine and return all unused affected product manufactured before 11-JUL-2020.
This action has been closed out on 16/03/2022 |
| Contact Information |
02 9857 9000 - Medtronic Customer Service |