Field Safety Notice Boston Scientific AXIOS™ Stent and Electrocautery Enhanced Delivery System (ICN 3198)

NHS Supply Chain Reference: 88

Alert:

• Boston Scientific has issued an urgent Field Safety Notice initiating a removal of certain AXIOS™ Stent and Electrocautery Enhanced Delivery Systems due to increased reports of stent deployment and expansion issues with these configurations.
• This issue 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 issue.
• Boston Scientific advise 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.
• The serious injury events also included three deaths; these events were associated with use outside of indication (EDGE procedure, gastrojejunostomy) or investigational use (AXIOS GE for GOO IDE study) and required a cascade of events with special circumstances such as decision for palliative care, altered anatomy or acute unrelated procedural complication, all of which limited further treatment options.

Recommendations:

• The supplier advises that patients who have been treated with a successfully implanted AXIOS™ stent should continue to follow standard of care, as the issue 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.
• Boston Scientific reminds healthcare professionals that AXIOS Stents should only be used as indicated in Instructions for Use.

Products Affected:

• Three of the affected products have been supplied via NHS Supply Chain’s eDirect Service:

• Please note only the lot numbers quoted in the Field Safety Notice are affected.
• The affected products are suspended and are currently unavailable to order.
• Boston is yet to advise when supply of these products will resume.
• Other sizes in the AXIOS range remain available. Customers are advised to consult your own clinical experts to ensure suitability for your organisation’s use of alternative products. 

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Immediately discontinue use of the Boston Scientific product reported in the list and remove all of the affected units from your inventory, regardless of where these units are stored in your facility.
• Segregate the units in a secure place, pending return to Boston Scientific.
• Complete the attached Verification Form, page 12 of the notice, even if you do not have any product to return.
• Return the completed Verification Form to your local Boston Scientific office for the attention of uk-quality@bsci.com on or before 26 January 2026.
• On receipt of the completed form, Boston Scientific will contact you to arrange collection.
• Please also contact your NHS Supply Chain Customer Service Advisor with full details, including quantities and lot 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.

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.