Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 36803 |
| Brand Name: | ELLA DANIS stent |
| Model: | SX-Ella Danis Stent – Danis Procedure Pack - Basic |
| Affected: | Multiple batches |
| Software version: | |
| Recalling Organisation: | Endotherapeutics NZ Limited 2B Target Court Wairau Valley Auckland 0627 |
| Contact Information: | |
| Manufacturer: | Dr Karel Volenec Ella CS |
| Issue: | The manufacturer has identified that the safety lock of the Y-connector may become loose (unscrewed) because it may not have been fixed by adhesive as required. If the blue nut is unscrewed, the gastric balloon of the Danis Stent delivery system cannot be inflated because the system is no longer fully airtight. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 14/5/2026 |
