| TGA Action ID |
RC-2025-RN-00636-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Carotid WALLSTENT Monorail Endoprosthesis
GTIN numbers: 08714729263869, 08714729263876, 08714729263883, 08714729263890, 08714729263906, 08714729263913, 08714729263920
Multiple batches |
| ARTG Number |
166856 |
| Action Type |
Recall |
| Action Level |
Consumer |
| Hazard Classification |
Class II |
| Reason for the Action |
Boston Scientific is recalling certain batches of Carotid WALLSTENT Monorail Endoprosthesis (Carotid WALLSTENT) devices due to an increase in complaints in which physicians described encountering greater than anticipated resistance when attempting to withdraw/retract the stent delivery system (SDS) from the guidewire or embolic protection device (EPD), after successful stent deployment.
The affected device batches were manufactured with equipment settings that led to an unintended change resulting in the inner guidewire lumen being narrower than the specified dimensions.
If the EPD contains debris, it may dislodge and embolise into cerebral vessels, potentially causing a life-threatening stroke (CVA), though not yet reported. Retraction through the carotid artery and WALLSTENT may be difficult, risking vessel injury, spasm, or stent damage, possibly requiring further intervention.
The most common problem observed is procedural delay beyond the expected timeframe. |
| Instructions for Customers/Users |
- There is no need for any further specific patient management related to the problem if the Carotid WALLSTENT was successfully utilised and the procedure has been completed. Standard post-procedure care is appropriate.
- Customers are advised to immediately cease further distribution or use of any remaining affected devices and to return them to Boston Scientific.
- A local sales representative will work with affected customers on obtaining a credit for returned devices. |
| Action Commencement Date |
16/07/2025 |
| Responsible Entity |
|
| Contact Information |
ANZ_Incident_Report@bsci.com - Boston Scientific Representative |