Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 37433 |
| Brand Name: | NAV- Passive Spheres |
| Model: | NDI Passive Sphere – Model No. 8801071, 8801074, 8801075 (specific lots) |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Medtronic New Zealand Limited Unit 16 Mezzanine Level 5 Gloucester Park Road Onehunga AUCKLAND |
| Contact Information: | 0800 377 807 |
| Manufacturer: | Northern Digital Inc |
| Brand Name: | CST - NAV - Surgical Procedure Kit, general purpose |
| Model: | Medtronic Biopsy Needle Kit – Model No. 9733068 (specific lots) |
| Affected: | |
| 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 Navigation Inc |
| Issue: | The manufacturer c has identified variability in the reflective material applied to a limited number of NDI Sterile Passive Sphere lots. The reflective coating is used to reflect infrared light from optical tracking cameras, allowing optical navigation systems to detect and track instruments during surgical procedures. The affected spheres may not be detected or tracked as intended by compatible navigation systems. This may result in instrument verification failures, intermittent or complete loss of tracking, tracking status errors, or reduced navigation accuracy. The variation in reflective material is not visually detectable and affected spheres cannot be reliably distinguished from unaffected spheres through inspection. This variability also affects specific lots of the Medtronic Passive Biopsy Needle as the needle includes two NDI passive spheres built within the instrument. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Healthcare Professional |
| Date Commenced: | 1/9/2026 |
