FDA-Device2026-10-16Class II
Medtronic NDI Passive Spheres REF: 8801071, Sterile EO, 1/Tray 12 pk., Rxonly
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.
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
14210 units
Manufactured in
200 Medtronic Dr, Lafayette, Colorado, United States
Products
Medtronic NDI Passive Spheres
REF: 8801071, Sterile EO, 1/Tray 12 pk., Rxonly
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0194-2027More Medtronic Navigation, Inc. recalls
- FDA-Device2026-10-16Medtronic NDI Passive Spheres REF: 8801075, Sterile EO, 5/Tray 12 Pk., Rxonly
- FDA-Device2026-10-16Medtronic Biopsy Needle Kit, REF: 9733068, Passive, Sterile EO, Rxonly
- FDA-Device2026-10-16Medtronic NDI Passive Spheres REF: 8801074, Sterile EO, 4/Tray 12 Pk., Rxonly
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