Field Safety Notice Boston Scientific Imager II Angiographic Catheters (ICN 3465)

NHSSC: 57

Alert:

• Boston Scientific has issued Field Safety Notice 97654746-FA recalling the Imager ll Angiographic Catheter range due to a manufacturing issue affecting the catheter tip.
• The supplier determined the affected products were manufactured with reduced levels of stabilising agents in the tips. This may increase the risk of tip degradation and detachment.
• The most common adverse health consequence of tip detachment in the intravascular space with a likelihood of occurrence of every time used is a delay in procedure to exchange for a new device. Although considered remote, the most serious potential adverse health consequence within the intravascular space is life threatening embolism resulting from a device fragment obstructing blood flow resulting in end organ failure.
• Boston Scientific advise they although have received no increase in tip detachment complaints, the devices were manufactured outside the approved design specification and are being removed from the market.

Products Affected:

• 26 products are affected.
• 13 of 26 products are available via NHS Supply Chain’s eDirect service.
• Please refer to the product listing for full details of the 13 products affected.
• Please note only the products listed in Attachment 1, page three of the Field Safety Notice are affected.
• Boston Scientific advises it contacted customers in September 2025 to confirm it was discontinuing this range from 30 November 2026, or upon prior inventory depletion.
• We are working to identify alternative products and will be issuing ICN 3477 for details of the products being delisted shortly.

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 affected lot numbers.
• Complete the Verification Form included with the Field Safety Notice and return to Boston Scientific at: UK-Quality@bsci.com as soon as possible.
• Where there are products for return Boston will contact you to arrange collection.
• Please also contact your local NHS Supply Chain Customer Services Advisor with full details of the affected products for collection, including national product codes, Lot numbers and quantity. Your Customer Services Advisor will give you a unique CMS log number and will raise the appropriate 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.