Boston Scientific POLARx, POLARx FIT Cryoablation Balloon Catheters and SMARTFREEZE Cryoablation System Consoles (ICN 3311)

NHSSC: 1

Alert:

• Boston Scientific has issued Field Safety Notice 97251520D-FA initiating the recall of POLARx™ and POLARx™ Fit Cryoablation Balloon Catheters and POLARSHEATH™ Steerable Sheaths, and the decommissioning of SMARTFREEZE™ Cryoablation System consoles.
• In 2025, Boston Scientific made the decision to discontinue this cardiac cryoablation product line, and thereafter ceased manufacturing catheters and consoles.
• Given recent reports of atrio-esophageal (AE) fistula events despite occurrence rates remaining within expected and documented ranges Boston Scientific is accelerating discontinuation of the POLARx Cryoablation System.

Products Affected:

• 8 products are being recalled.
• Please refer to Table 1 found on page 2 of the notice for details on all affected products.
• 5 of the products affected by the recall have been sold via our eDirect service:

• 5 products are being decommissioned. Please note these products are not being recalled.
• Please refer to Table 2 found on page 2 of the notice for details on all affected products.
• 1 of the products affected by the decommission has been sold via our eDirect service:

• All the affected products are suspended and are no longer available to order.
• Potential indirect alternative products are available to order through our online catalogue.
• See our Downloads ▼ section to access the product listing for further information on the affected products and potential alternatives.
• Where potential alternatives are identified, customers are advised to consult your own clinical experts to ensure suitability for your organisation’s use of these products.

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 the products affected by the recall.
• Complete the Verification Form, found on page 4 of the notice, and return to: UK-Quality@bsci.com on or before 27 April 2026.
• In the Product Table on the form, list only the recalled devices (POLARx / POLARx FIT catheters and POLARSHEATH sheaths) by entering the UPN, Lot/Batch number, and Quantity.
• After receipt of the Verification Form, Boston Scientific will contact you to arrange return.
• Please also contact your local NHS Supply Chain Customer Service Advisor with details of the products being returned to enable us to manage your credit.

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