Device safety informationMHRA
Updated guidance on the management of the recalled Endologix Nellix safety warning over a safety concern
The MHRA provides an update to previous guidance on the management of patients treated with the recalled Endologix Nellix EVAS System to reflect revised recommendations. All implanted patients in the UK with this device should be identified and appropriate action taken.
What to do now
The MHRA has published safety information about Updated guidance on the management of the recalled Endologix Nellix.
- Speak to the clinic, hospital or supplier who gave you the device before changing how you use it.
- Check the model, lot or serial number against the details on this page.
- Any incident involving the device can be reported through the Yellow Card scheme.
Why it matters. Device safety information tells healthcare staff and, where relevant, patients about risks and the actions needed.
Replacements and support
Speak to the supplier, clinic or hospital that gave you the device. They will know whether yours is affected and what happens next.
Do not throw away a device you rely on until a replacement has been arranged.
From the official notice
Published by the Medicines and Healthcare products Regulatory Agency (DSI/2025/004). Quoted as issued.
Summary
The MHRA provides an update to previous guidance on the management of patients treated with the recalled Endologix Nellix EVAS System to reflect revised recommendations. All implanted patients in the UK with this device should be identified and appropriate action taken.
The risk
Summary Following a review, the MHRA provides an update to previous guidance on the management of patients treated with the recalled Endologix Nellix EndoVascular Aneurysm Sealing (EVAS) System to reflect revised recommendations. All implanted patients in the UK with this device should be identified and appropriate action taken. Advice for Healthcare Professionals
Advice for healthcare professionals
Following a review, the MHRA provides an update to previous guidance on the management of patients treated with the recalled Endologix Nellix EndoVascular Aneurysm Sealing (EVAS) System to reflect revised recommendations. All implanted patients in the UK with this device should be identified and appropriate action taken.
previous MHRA advice regarding management of implanted patients with these devices has now been superseded (see ‘Explanation of identified safety issue’ section)
healthcare professionals should identify, assess and treat patients with these devices in line with the updated recommendations from the European Society for Vascular Surgery (ESVS) Abdominal Aortic Aneurysm Clinical Practice Guidelines 1
refer to the ESVS guidelines for comprehensive steps for patient management, in summary you should:
identify all patients with an implanted Nellix device at your centre
inform patients regarding the high mid- and long-term failure rates of EVAS and explain potential problems that may occur
enrol patients in enhanced surveillance, for those deemed necessary
for patients with a failing Nellix implant, early elective explantation is recommended as the preferred treatment in surgically fit patients
if you are implanted with one of these devices you will be contacted by your treatment centre. They will discuss the risks associated with your device and the options available to you depending on your circumstances
if you experience any symptoms such as pain, numbness, or weakness in the legs back, chest or abdomen, dizziness, fainting, or rapid heartbeat, please seek urgent medical attention 2
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Advice for patients
if you are implanted with one of these devices you will be contacted by your treatment centre. They will discuss the risks associated with your device and the options available to you depending on your circumstances
if you experience any symptoms such as pain, numbness, or weakness in the legs back, chest or abdomen, dizziness, fainting, or rapid heartbeat, please seek urgent medical attention 2
Open the MHRA notice
Questions
Why has Updated guidance on the management of the recalled Endologix Nellix been recalled?
The MHRA has published safety information about Updated guidance on the management of the recalled Endologix Nellix. Device safety information tells healthcare staff and, where relevant, patients about risks and the actions needed.
How do I know if my product is affected?
The notice describes the affected product rather than listing codes. Compare the product name, pack size and where you bought it with the official notice.
What should I do now?
Speak to the clinic, hospital or supplier who gave you the device before changing how you use it. Check the model, lot or serial number against the details on this page.
Who replaces the device?
Speak to the supplier, clinic or hospital that gave you the device. They will know whether yours is affected and what happens next. Do not throw away a device you rely on until a replacement has been arranged.