Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 25037 |
| Brand Name: | Coronary - Rapid Exchange Balloon Dialation Catheter |
| Model: | |
| Affected: | 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 determined that some catheters have a slightly higher diameter stylette causing removal difficulties. If stylette removal difficulties are encountered, there is the potential for damage to the balloon or catheter due to excessive force being applied, and this may lead to balloon inflation or deflation challenges. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 30/8/2019 |
