FDA-Device2026-10-16Class IIPROCESSING DEFECT
Medtronic NDI Passive Spheres recalled for reflective material variation affecting navigation system tracking
What this means
Medtronic NDI Passive Spheres used in surgical navigation systems contain a variation in their reflective material coating. This variation may prevent the navigation system from reliably detecting and tracking the spheres during surgery.
- Contact Medtronic if you have the affected lot codes (2503141 through 2511601)
- Do not use affected units until you receive replacement guidance from Medtronic
- Return affected units to Medtronic for replacement or credit
The agency's original wording
Hazard
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
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,
Affected count
83,594 units
Manufactured in
200 Medtronic Dr, Lafayette, Colorado, United States
Products
Medtronic NDI Passive Spheres
REF: 8801074, Sterile EO, 4/Tray 12 Pk., Rxonly
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0195-2027More Medtronic Navigation, Inc. recalls
- FDA-Device2026-10-16Medtronic NDI Passive Spheres recalled for defective reflective material affecting navigation system tracking
- FDA-Device2026-10-16Medtronic NDI Passive Spheres recalled for reflective material variation affecting surgical navigation tracking
- FDA-Device2026-10-16Medtronic Biopsy Needle Kit recalled for navigation tracking defect
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