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Originator: MHRA Medical Device Alerts

Issue date: 25-Jan-2019 11:00:22

This alert has been issued to:
  • 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

  • Other contacts
  • Independent Healthcare Providers (registered with CAS)
  • Clinical Commissioning Groups
  • Special Health Authorities

Action category: Action

Title: Nellix Endovascular Aneurysm Sealing (EVAS) System - Device recall and enhanced patient surveillance

Broadcast content: 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.

Additional information: NHS England Regional offices: do not cascade to primary care.

Alert reference: MDA/2019/002

Action underway deadline: 01-Feb-2019

Action complete deadline: 15-Feb-2019

Attachments:

Contact our helpdesk

Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency