Nav- Passive Spheres

NAV Passive Spheres Recall Summary Medtronic is recalling certain lots of NDI Passive Sphere optical tracking devices and Medtronic Biopsy Needle Kits used during surgery because the reflective coating on some spheres may not work properly. The reflective material on affected devices may not reflect infrared light as intended, which could cause surgical navigation systems to lose tracking of instruments during procedures or provide inaccurate positioning information. The defect is not visible to the naked eye, so affected devices cannot be identified through visual inspection alone.

Recalling firm

Medtronic New Zealand Limited

Product

NAV- Passive Spheres. [Device]. Model: NDI Passive Sphere – Model No. 8801071, 8801074, 8801075 (specific lots); Medtronic Biopsy Needle Kit – Model No. 9733068 (specific lots). Also covers: CST - NAV - Surgical Procedure Kit, general purpose

Reason

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...

Classification

Class I

Category

medical device recall

Country

New Zealand

Agency

MEDSAFE

Recall date

2026-09-01

Status

Ongoing

Distribution

New Zealand - Healthcare Professional

Official recall notice from MEDSAFE

Recall details on Nibble Recalls: https://trynibble.app/recalls/a86f2fd6-35aa-4eb3-bfe1-2bf934320282