| TGA Action ID |
RC-2025-RN-01077-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
AXIOS Stent and Electrocautery Enhanced Delivery System
UPN : M00553520, M00553530, M00553560
GTIN: 08714729904540, 08714729904557, 08714729951100
Multiple lot numbers |
| ARTG Number |
282177 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class I |
| Reason for the Action |
Boston Scientific is initiating a removal of certain AXIOS Stent and Electrocautery Enhanced Delivery Systems (6 mm × 8 mm, 8 mm × 8 mm, and 20 mm × 10 mm), due to increased reports of stent deployment and expansion problems with these configurations.
This problem only occurs at the time of delivery of the stent and is expected to be noticed by the physician. Successfully implanted stents are not affected by this problem.
The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one.
The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site. |
| Instructions for Customers/Users |
Customers should:
1. Immediately stop further distribution or use of any remaining affected devices and remove them from their facility’s inventory and segregate them in a secure location.
2. Return affected devices to Boston Scientific as per the instructions provided in the customer letter.
Patients who have been treated with a successfully implanted AXIOS stent should continue to follow standard of care, as the problem only occurs at the time of delivery of the stent. Any additional management should be at the discretion of their physician based on individual circumstances. |
| Action Commencement Date |
19/12/2025 |
| Responsible Entity |
|
| Contact Information |
ANZ_Incident_Report@bsci.com |