Medtronic Navigation, Inc.: Neurological Stereotaxic Instrument
Recall Summary Medtronic Navigation is recalling Passive Spheres (sterile tracking devices used in neurological surgery navigation systems) because variations in their reflective coating may prevent the navigation system from properly detecting and tracking them during procedures. The affected product (reference 8801071) was distributed throughout the United States, Puerto Rico, and several international locations including parts of China, Taiwan, and Hong Kong.
- Recalling firm
- Medtronic Navigation, Inc.
- Product
- Medtronic NDI Passive Spheres REF: 8801071, Sterile EO, 1/Tray 12 pk., Rxonly
- Reason
- Sterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation system to detect and track the spheres.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-08-31
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA VT WA WI WV WY OUS: Canary Islands, Iceland, Northern Ireland, Martinique, China , Taiwan, Hong Kong,
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/398dd799-080e-410e-a2a9-cc3b0d8cdc19