Field Safety Notice Medtronic EOPA™ Arterial Cannulae (ICN 3396)

NHSSC: 30

Alert:

• Medtronic has issued Field Safety Notice FA1573 following reports of pinhole leaks in the wire-wound body of the 22fr EOPA 3D arterial cannulae used during cardiopulmonary bypass procedures.
• Evaluation of returned devices confirmed the presence of a small pinhole defect located near the fifth-sixth spring wire coil beyond the final depth marking on the cannula body. This may not be visible during routine inspection and is typically only detectable when the cannula is flexed.
• Potential risks associated with this condition may include hypovolemia, vessel laceration or perforation, ischemia and organ dysfunction.
• Medtronic advise they have received no reports of adverse patient outcomes.

Products Affected:

• There are six products affected:
  • FXA082, FXA051, FXA124, FXA102, FXA341 and FXA562.
• The six products affected are available via NHS Supply Chain’s eDirect service.
• Please refer to the product listing attached for full details of the affected products.
• Please note only the lot numbers quoted in Attachment A page 4 of the Field Safety Notice are affected.
• Medtronic expects to begin receiving initial recovery lots within the next 8-10 weeks, with full recovery expected between late September and early October 2026.
• NHS Supply Chain is actively seeking alternative products.
• See our Useful Links section to view ICN 3338 which covers pre-existing issues in this product area. This ICN will be updated as further information on supply and alternatives becomes available.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Complete Medtronic’s Customer Acknowledgment Form, Attachment B, page 5 of the Field Safety Notice even if you do not have any of the affected products and return to: fsnuki@medtronic.com.
• Medtronic will arrange collection of your affected devices.
• Please also contact your local NHS Supply Chain Customer Services Advisor with full details of the affected products in your possession, including product codes, lot numbers and quantity. Your Customer Services Advisor will give you a unique CMS log number and raise customer credit where appropriate.
• Where potential alternatives are identified, Customers are advised to consult your own clinical experts to ensure suitability for your organisation’s use of these products.

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.