Supply Issues Multiple Suppliers Perfusion Cannulas (ICN 3338)

• The supply issue with perfusion cannulas from multiple suppliers is continuing.
• 178 products remain affected in total.
• 172 products are subject to intermittent supply.
• Six Medtronic product codes are now subject to Medtronic’s “Manual Allocation” as a result of the recent Field Safety Notice, issued by Medtronic, communicated via our ICN 3396:
  • FXA082, FXA051, FXA124, FXA102, FXA341 and FXA562.
• See our Useful Links section to view ICN 3396.
• See our Downloads ▼ section to view an Information for Clinical Choice Product Matrix for clinicians to view alternatives for arterial cannulas; the highlighted six products on the Medtronic Tab are in relation to Field Safety Notice ICN 3396.
• Potential alternatives are available via Edwards (EnableCV), Medtronic and LivaNova, through our framework.
• Potential alternatives are available via the Chalice Andocor range which is outside of the framework.
• We are actively sourcing alternatives for both venous and arterial and will update this ICN as soon as possible.
• See our Downloads ▼ section to access the product listing for further information on the affected product codes and the Information for Clinical Choice Product Matrix.
• We do not currently have a resolution date for the supply issue and will update this ICN as soon as we have further information.

Change:

• The suppliers Medtronic, LivaNova and Edwards Lifesciences (EnableCV) have informed us of a supply issue with their arterial cannulae, venous cannulae, two-stage venous, single stage venous, coronary ostial and femoral cannula products.
• There are 178 product codes affected across three suppliers.
• The supply issue is due to supplier manufacturing issues.
• Medtronic have been transitioning some of their cannula ranges over to EU Medical Device Regulation (EU MDR) upgrade specifications, which are necessary to maintain the regulatory compliance with EU MDR.
• LivaNova are seeing an increased demand in its products resulting in some backorders.
• Edwards Lifesciences (EnableCV) are also facing an unprecedented manufacturing demand on their products.

Impact:          

• All affected product codes are currently subject to intermittent supply.  
• Alternatives are available through all three suppliers; trusts are advised to speak to the supplier directly to source suitable alternatives.
• Suppliers are working closely with trusts to ensure suitable alternatives based on current stock availability.
• See our Downloads ▼ section to access the product listing for further information on the affected product codes.
• The supply issue is anticipated to be resolved by end of July 2026.

Next Steps:              

• Customers are advised to log into our website to view the product listing for further information on the affected product codes.
• The continuing supply issue is being monitored in conjunction with the suppliers, and we will continue to review the stock situation to minimise further disruption and update this ICN with the latest information as it becomes available.
• However, as this is currently a disrupted market and supply is subject to rapid change, the alternatives offered may also be experiencing temporary supply issues and therefore, customers may need to consider clinically reviewing all additional alternatives provided.
• If you have any further questions, please contact your local NHS Supply Chain Customer Services Advisor.

Please note that due to the clinical nature of these alternative products, we advise you to consult your own clinical experts to ensure suitability for your organisations use of these products.