Field Safety Notice Boston Scientific RELIANCE ePTFE Defibrillation Lead Gradual Rise in Shock Impedance (ICN 3044)

NHSSC: 56

Alert:

• Boston Scientific has issued a Field Safety Notice to provide important information about RELIANCE ePTFE (Gore) defibrillation leads with an increased potential to exhibit a pattern of gradual rise in LVSI which is associated with calcification of the shocking coil(s).
• This calcification may reduce the shock efficacy and increase the risk of harm, including early lead replacement or failure to treat life threatening arrhythmic events.

Products Affected:

• The affected leads were manufactured by Boston Scientific from 2002 to 2021 and were available during this period on the eDirect service via NHS Supply Chain.
• See our Downloads ▼ section to view the product listing for further details.
• These leads are no longer available.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Post the Field Safety Notice in a visible location near the product to ensure the information is easily accessible to all users of the device.
• Inform relevant healthcare professionals and organisations about the notice.
• Complete the Acknowledgment Form, even if you do not have any affected product, and return to: uk-Quality@bsci.com before 22 August 2025.
• A patient letter is available if required.
• See our Downloads ▼ section to access the patient letter.

If you have any further questions, 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.