| TGA Action ID |
RC-2026-RN-00669-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
NDI Passive Spheres and Medtronic Biopsy Needle Kit
Product Descriptions: SPHERES 8801071 1/TRAY 12PK, SPHERES 8801074 4/TRAY 12PK, SPHERES 8801075 5/TRAY 12PK and BIOPSY NEEDLE KIT 9733068 PASSIVE
Model Numbers: 8801071, 8801074, 8801075, 9733068
Multiple lot numbers |
| ARTG Number |
119035, 196655 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Medtronic 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.
As of July 30, 2026, Medtronic has not identified any complaints confirmed to be associated with this problem. |
| Instructions for Customers/Users |
Customers are to:
• Immediately locate and quarantine all unused impacted product(s). See Attachment A for affected Medtronic lot numbers.
• Return unused impacted product(s) to Medtronic following the instructions in the enclosed Customer Response Form.
• Complete the Customer Response Form and return it to Medtronic at rs.anzrecalls@medtronic.com |
| Action Commencement Date |
3/09/2026 |
| Responsible Entity |
|
| Contact Information |
0456995887 regarding Biopsy Needle, 0434815851 regarding Spheres product line - Medtronic |