Product Recall Medtronic Pipeline Vantage Embolization Device Shield Technology (ICN 2829)

MHRA: 34594119

NHSSC: 90

Alert:

• Medtronic has issued a Field Safety Notice initiating a product recall of the Pipeline Vantage devices with the part numbers PED3-027-xxx-xx, which represents compatibility to 0.027inch (0.69mm) inner diameter microcatheters “Pipeline Vantage 027”.
• The Field Safety Notice also includes a product correction to the Instructions for Use (IFU) for Pipeline Vantage devices with the part number PE3-021-xxx-xx, which represents compatibility to 0.021inch (0.53mm) inner diameter (ID) microcatheters “Pipeline Vantage 021”.
• Medtronic has taken this action following reports of incomplete wall apposition and/or braid deformation noted during and post procedure.
• Braid deformation (sometimes termed “fish-mouthing”, “braid narrowing,” or “braid collapse”) and incomplete wall apposition are known risks that potentially can lead to thrombosis and/or serious adverse events including stroke or death.

Products Affected:

• The products affected are available on the eDirect route from NHS Supply Chain.
• Please refer to the product listing for full details of the Pipeline Vantage 027 devices for recall, along with Appendix C.
• Medtronic advise they are in direct contact with customers that have received the affected Lots.
• Pipeline Vantage 027 products are currently unavailable to order. We will update this ICN once a recovery date is known.
• For Pipeline Vantage 021 devices, subject to the revised Instructions for Use (IFU), please refer to the product listing along with Appendix B.
• A range of alternative products can be found in the product listing. Customers are advised to consult your own clinical experts to ensure suitability for your organisation’s use of these products.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.

Pipeline Vantage 027 Devices

• Do not use any impacted Pipeline Vantage 027 listed in Appendix C of the notice.
• Remove the unused devices from your inventory and quarantine, pending collection by Medtronic.
• Complete Medtronic’s Customer Acknowledgement Form, even if you do not have affected inventory, and email to: regulatoryuk-ire@medtronic.com no later than 31 May 2025.
• On receipt of the completed form Medtronic will contact you to arrange collection of the affected Vantage 027 devices in your possession.

Pipeline Vantage 021 Devices

• Medtronic is implementing changes to the IFU for the Pipeline Vantage 021 with part numbers PED3-021-XXX-XX. The purpose of these changes is to help achieve optimal size selection and stent braid deployment to reduce the risk of complications and patient harms.
• Medtronic strongly recommend the following the redlined/proposed IFU language found in Appendix C of the notice while they work through the regulatory approval process to make these changes permanent.
• Share this notice and the updated IFUs with all users of the affected products and ensure the updated IFU is used when completing any future procedure with the Pipeline Vantage 021 device.

If you have any questions regarding this communication, please contact your Medtronic representative or telephone: 01923 205 167.

If you have any further queries, please contact your local NHS Supply Chain Customer Service Advisor or the Hospital Care 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.