Field Safety Notice Terumo Gelsoft Plus, Gelweave and Thoraflex Hybrid Devices (ICN 3287)

NHSSC: 116

Alert:

• Terumo issued Field Safety Notice FSN2025-003 in December 2025 following customer feedback regarding expiry dates on certain device ranges. Further investigation which included a100% verification check of each MDR device labelling confirmed a deficiency in the shelf life.
• The expiry date shown on the labelling for the affected devices is one month longer than approved:
  • For Gelweave and Gelsoft Plus devices, the expiry date is displayed as 37 months from the date of manufacture. This should be 36 months.
  • For Thoraflex Hybrid devices, the expiry date is displayed as 25 months from the date of manufacture. This should be 24 months.
• Terumo advise the technical data available at the time of this assessment indicate that the device safety and performances if implanted during the final month prior to expiry date remains as per design specification and that the devices are fit for purpose and their intended performance is not affected by the 1 month discrepancy of the indicated shelf life, clinical performance and benefits are expected to be as intended by the manufacturer.

Products Affected:

• 277 affected products are available via NHS Supply Chain.
• Please see the attached product listing and Field Safety Notice for more information and details on the affected products.
• Affected item codes (manufactured since Apr 2025) can be identified as per the below, with supporting images to help identification found in section 2.2, page 2 of the Field Safety Notice:
  • All Thoraflex Hybrid devices (any devices item number ending ‘E-B’ e.g. THP2224X100E-B)
  • All Gelsoft Plus devices (any item number ending ‘E-B’ e.g. 631206PE-B)
  • All Gelweave devices (any item number ending ‘E-B’ e.g. 7320128/10RMEE-B).

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Complete the Customer Reply Form, found page 5 of the notice, and email to: fsn2025-003shelflife@terumoaortic.com
• The manufacturer does not request that any devices are returned, but affected stock may be sent back to the supplier for replacement devices on a voluntary, case by case basis.
• Terumo confirm they have identified and already contacted all affected customers.

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.