Ella Danis Stent
ELLA DANIS Stent Recall Summary The ELLA DANIS stent, distributed in New Zealand to hospitals, pharmacies, and laboratories, is being recalled by manufacturer Dr Karel Volenec Ella CS. The manufacturer is issuing guidance on how the product should be used. This is classified as a Class I recall, the most serious type.
- Recalling firm
- Endotherapeutics NZ Limited
- Product
- ELLA DANIS stent. [Device]. Model: SX-Ella Danis Stent – Danis Procedure Pack - Basic. Affected: Multiple batches
- Reason
- 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.
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-05-14
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/677ef14e-6802-4f0d-8b5f-ede95260a5ab