Supply Issues Olympus Keymed Lithotripsy Consumables FAL3501 (ICN 2664)

• The supply issue with Lithotripsy Consumables from Olympus Keymed is continuing.
• Due to the continuing issue FAL3501 is now in the process of being delisted from our online catalogue, this is due to be completed by 26 March 2025.
• This ICN is now closed.

• The supply issue with Lithotripsy Consumables from Olympus Keymed is continuing.
• One product code remains affected in total:
  • FAL3501 – Lithotripter BML v44qr 30 wireguided 4 2mm single use sterile.
• The affected product remains suspended and unavailable to order.
• Potential indirect alternative products are available to order through our online catalogue for the affected product. However, some of these products may also become subject to intermittent supply with the increase in demand.
• See our Downloads ▼ section to access the product listing for further information on the affected product code and potential alternatives.
• The supply issue is now anticipated to be resolved by 17 March 2025.

Change:

• The supplier Olympus Keymed has informed us of a supply issue with its Lithotripsy Consumables.
• One product code is affected:
  • FAL3501 – Lithotripter BML v44qr 30 wireguided 4 2mm single use sterile.
• The supply issue is due to Olympus Keymed withdrawing the product to complete design improvements by strengthening the device tip, reducing the chance of breakage when being loaded.
• For all current stock, additional care should be exercised when loading FAL3501 to ensure tip integrity.

Impact:

• The affected product is currently suspended and unavailable to order.
• Potential indirect alternative products are available to order through our online catalogue:
  • FAL2768 – Conquest ttc lithotripter cable with adapter cable 8 5 fr 170cm
  • FAL2769 – Conquest ttc cable with adapter cable 10fr 170 cm
  • FAL3502 – Bml v242qr 30 hard basket 4 2mm single use sterile.
• Trusts should factor in both training and compatibility when reviewing the available indirect alternatives. As a predecessor model, Olympus has advised that FAL3502 should fit the same handle as FAL3501 and, if required, training is available.
• The indirect alternatives provided are not wire-guided, and both FAL2768 and FAL2769 are of a different brand.
• Additional training may be required if clinicians have not used the alternatives provided. If additional training is required, suppliers should be contacted directly for support.
• See our Downloads ▼ section to access the product listing for further information on the affected product code and potential alternatives.
• Supply is expected to be disrupted until Olympus have completed the implementation of product improvements.
• The supply issue is anticipated to be resolved by 1 March 2025.

Next Steps:               

• Customers are advised to log into our website to view the potential indirect alternative products.
• The continuing supply issue is being monitored in conjunction with the supplier 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.