Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 21115 |
| Brand Name: | ELLA DANIS stent |
| Model: | |
| Affected: | Lot no: P14120205-01, P14110009-01, P14100164-01, P14070170-01, P14060264-01, P14030191-01, P14020256-01 |
| 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 an unintended movement of the safety valve of the fixation gastric ballon of the delivery system of the Danis Stent can occurr |
| Recall action type: | Recall |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 17/2/2017 |
