Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 26522 |
| Brand Name: | VAS - Rashkind Septostomy Balloon Catheters |
| Model: | |
| Affected: | 5F Rashkind Balloon Catheter Single Lumen, 4F Rashkind Balloon Catheter Single Lumen, 6F Rashkind Recessed Balloon Catheter - Multiple lots |
| Software version: | |
| Recalling Organisation: | Medtronic New Zealand Limited Unit 16 Mezzanine Level 5 Gloucester Park Road Onehunga AUCKLAND |
| Contact Information: | 0800 377 807 |
| Manufacturer: | Medtronic Inc |
| Issue: | The manufacturer has received complaints involving balloon integrity and subsequent failure that involved patient death and patient material embolisation. Material rupture / balloon failure during procedure can result in material embolisation, balloon leak, balloon burst, inversion or stretching resulting in balloon failure, or surgical intervention. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 8/9/2020 |
