Database updated: 3 November 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 29094 |
| Brand Name: | Advanta V12 Stent |
| Model: | |
| Affected: | All |
| Software version: | |
| Recalling Organisation: | Getinge Australia Pty Ltd (NZ) Unit D, Ground Floor, Building A, Millenium Centre 600 Great South Rd Ellerslie Auckland 1051 |
| Contact Information: | 09 272 9039 |
| Manufacturer: | Atrium Medical Corporation |
| Issue: | The manufacturer has received complaints of the balloon or catheter hub separating from the delivery catheter over a 3-year period, including one event involving occlusion of the renal artery with potential for loss of kidney function. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 11/3/2022 |
