Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 29154 |
| Brand Name: | VAS - InPact Admiral Paclitaxel-eluting PTA Balloon Catheter |
| Model: | Model: SBI06012013S - product code - SBI06012013S |
| Affected: | 0010875709 |
| 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: | During a routine inspection, the manufacturer noted that there was damage to the sterile pouch that contains the IN.PACT Admiral catheter. An investigation determined that there had been a change implemented to one manufacturing line which may cause pouch damage. All batches manufactured on this line after that change are being retrieved. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 23/3/2022 |
