| Originator: |
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MHRA Medical Device Alerts
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- Care Trusts
- Mental Health Trusts
- Specialists Trusts
- NHS Regional Offices
- Learning Disabilities Trusts
- Mental Health & Social Care Trusts
- Ambulance Trusts
- Mental Health & Learning Disabilities Trusts
- Acute Trusts
- Community Trusts
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- Other contacts
- Independent Healthcare Providers (registered with CAS)
- Clinical Commissioning Groups
- Special Health Authorities
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| Title: |
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Updated: Nellix Endovascular Aneurysm Sealing (EVAS) System - Device recall and enhanced patient surveillance
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| Broadcast content: |
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Endologix has stopped selling the Nellix EVAS device and is recalling unused stock. MHRA recommends enhanced patient surveillance due to a high risk of graft failure beyond two years after implantation.
Update includes further advice on how to detect features of Nellix endograft failures. This advice has been produced by MHRA’s Nellix independent Expert Advisory Group.
Note: This Medical Device Alert (MDA) updates guidance previously given in MDA/2019/002 issued 25 January 2019.
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| Additional information: |
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NHS England Regional offices:
Do not cascade to primary care
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| Action underway deadline: |
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08-May-2019
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| Action complete deadline: |
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22-May-2019
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