Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 20039 |
| Brand Name: | Endologix Nellix Endovascular Aneurysm Sealing System |
| Model: | N10-100, N10-110, N10-120, N10-130, N10-140, N10-150, N10-160, N10-170, |
| Affected: | |
| Software version: | |
| Recalling Organisation: | eVas Medical 73 Churchill Road Murrays Bay Auckland 0630 |
| Contact Information: | |
| Manufacturer: | Endologix LLC |
| Issue: | Updated Instructions for Use (IFU) for the Nellix EndoVascular Aneurysm Sealing System. Feature that differentiates Nellix from other AAA endovascular devices is the use of a 2-part water soluble polymer that is used to fill the aneurysmal space. During the Nellix procedure, polymer is dispensed through fill tubes within the catheter into endobags which surround the stent grafts. The polymer is introduced in a liquid form and begins to crosslink as soon as the components are mixed. Complete crosslinking occurs inside the endobags 3 to 5 minutes after filling has been completed. The polymer will not crosslink in the fill tubes, as long as there is continuous flow of the solution. Once the polymer stops moving through the fill tubes, crosslinking can occur in 30 seconds within the fill tubes. If the polymer cures in the fill tubes, it can impede further introduction of polymer.Utilization of the secondary fill option (outline din IFU) is necessary to safely compete the filling process. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 19/4/2016 |
