Field Safety Notice Boston Scientific OptiCross™ Intravascular Ultrasound (IVUS) Imaging Catheters (ICN 3528)

NHSSC: 81

Alert:

• Boston Scientific has issued advisory Field Safety Notice 97660164-FA regarding the OptiCross™ family of intravascular ultrasound (IVUS) imaging catheters to communicate an update to the flushing instructions, reinforce device preparation and air-management practices, and inform users of upcoming updates to the Instructions for Use (IFU).
• Please note this advisory notice applies only to the products listed in Attachment 1.
• Boston Scientific is implementing these IFU updates in response to reports of air embolism events and reports of repeated flushing to restore image quality while the catheter was positioned within the patient.
• The company advises its investigation concluded the reported air embolism events were not associated with the OptiCross™ IVUS catheter design or manufacture. Device testing demonstrated that completing all three flushing steps currently specified in the IFU prior to use reduces residual air within the catheter.
• The risk of air embolism is a known risk inherent to percutaneous procedures, including procedures involving intravascular imaging with the OptiCross™ catheter, and is identified in the current IFU.

Products Affected:

• 26 products are affected.
• Six of the products affected are available via NHS Supply Chain’s e direct service.
• See our Downloads ▼ section to access the product listing for further information on the affected product codes.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Customers are instructed to complete the acknowledgment form, even if they no longer have any product and return to: UK-Quality@bsci.com on or before 10 November 2026.
• Please note this is an advisory notice no product is being withdrawn or recalled.
• Boston Scientific has confirmed it has contacted all customers potentially affected by this issue.
• 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.