Field Safety Notice GORE® ACUSEAL Vascular Graft (ICN 3114)

NHSSC: 74

Alert:

• L. Gore & Associates (Gore) issued a Field Safety Notice in August 2025 regarding the updating of the Instructions for Use (IFU) related to the GORE® ACUSEAL Vascular Graft, all catalogue numbers, following a number of reports of delamination.
• The GORE® ACUSEAL Vascular Graft is composed of multiple layers. Delamination refers to the separation of these layers. If delamination occurs, the separated material may protrude into the lumen.
• Harms associated with delamination may include reduced access flow due to stenosis, thrombosis, or occlusion; cannulation difficulties; bleeding or bruising; and harms related to reintervention procedures performed to address the delamination.
• To date, investigation has not revealed any design or manufacturing deficiencies related to delamination.
• Gore will be updating its Instructions for Use (IFU) for the products affect. Please see the Field Safety Notice for full details.

Products Affected:

• Two of the products affected are available from NHS Supply Chain:

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Complete the Acknowledgement Form, found on page 7 of the Field Safety Notice and return to: FieldActionTeam@wlgore.com

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.