Field Safety Notice Boston Scientific Carotid WALLSTENT™ Monorail Endoprosthesis (ICN 3068)

NHSSC: 63

Alert:

• Boston Scientific has issued a Field Safety Notice regarding batches of Carotid WALLSTENT™ Monorail Endoprosthesis (Carotid WALLSTENT) devices.
• There has been an increase in complaints received by Boston Scientific 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.
• Due to the guidewire lumen restriction, the inability to withdraw the SDS results in the need to remove the SDS and EPD as a system while the EPD is still deployed. If the EPD contains debris, this may be dislodged and spill into the bloodstream with consequent embolization into the cerebral vasculature. Although not observed in any of the reported complaints to date, the most serious potential adverse health consequence would be a life-threatening cerebrovascular accident (CVA)/stroke.
• Additionally, there may be difficulty in retracting the deployed EPD through the carotid artery and Carotid WALLSTENT which may result in vessel injury, vessel spasm or stent disruption/damage necessitating additional endovascular or surgical interventions.

Products Affected:

• The affected products are available from NHS Supply Chain’s eDirect route.
• Please refer to the product listing for full details.
• Only batches from page 3 of the Field Safety Notice are affected.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Cease use and quarantine all products with the affected batch numbers.
• Contact the supplier to arrange collection of affected products by completing the Customer Verification Form, found page 12 of the notice, and return to uk-Quality@bsci.com
• Please note completed forms must be received by Boston Scientific no later than Friday 19 September 2025.
• Please also contact your NHS Supply Chain Customer Service Advisor with full details, including quantities and batch numbers you are returning to the supplier to enable us to manage your credit where appropriate.

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor or the Hospital Care team.

Please be aware that in the event of a Field Safety Notice/Product Recall we may need to provide manufacturers, UK responsible Persons and Distributers with contact details of customers who have potentially received the affected stock. This is to help them to reconcile their stock and evidence to the regulators that all actions have been taken to ensure that the unused products have been removed from customers to prevent inadvertent use of faulty and potentially unsafe products.