Voluntary recall of Nellix® EndoVascular Aneurysm Sealing System (all model numbers / serial numbers)

Qualtech Consulting Corporation Pte. Ltd. would like to inform healthcare professionals of the voluntary recall of all models and serial numbers of the Nellix^® EndoVascular Aneurysm Sealing System  (“Nellix^® System”). The product owner, Endologix, is ceasing unrestricted sales of these devices and requesting for all unused devices to be returned. This action is due to adverse events including migration, Type 1 endoleak, and aneurysm enlargement, that Endologix predominately attributes to use outside of the current indications. Endologix has previously issued several letters to update labelling, detail procedural best practices, and train on appropriate use of the affected device. Healthcare professionals are recommended patient-tailored surveillance for existing patients on the endovascular implant.  Please refer to the letter for details.

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://hpp.moh.gov.sg and follow the procedures below to access the MOH Alert system.

Step 1: Select your profession under ‘For Healthcare Professionals’.

Step 2: Click on ‘Useful links’.

Step 3: Click on ‘MOH Alert’ and log in via Singpass.

Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.