Field Safety Notice Optimed Tentos 4FBare Metal Self Expanding Stents (ICN 3231)

MHRA:   38473763  2026/002/009/601/046

NHSSC: 103

Alert:

• Optimed has issued a Field Safety Notice RE-25-021 recalling specific batch numbers of Tentos 4Fbare metal self-expanding stents following reports of internal catheter breakage.
• The Tentos 4F stent system is used to insert a self-expanding Nitinol stent into the arterial vascular system in the pelvic/leg area using the application system. The stent itself is designed to improve the lumen diameter of the target vessel and blood flow.
• Due to insufficient elasticity of the polyimide inner catheter, there is a risk of failure at the transition from the proximal crown to the filler material. After release of the stent, this can lead to loosening of the inner structure distal to the transition form the crown marker to the filler material.
• The possible consequence is the inner structure detaches and remains in the vessel leading to complications.

Products Affected:

• A total of 96 products are affected.
• Nine of the affected products have been supplied via NHS Supply Chain on our eDirect service, please see the product listing for full details.
• Please note only the batch numbers quoted in the Field Safety Notice are affected.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• HC21 Group for Aqualant the UK distributor confirm the four trusts receiving affected batches via NHS Supply Chain, have been contacted, the affected devices collected and replacements in the process of or have been provided to the end user.

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.