Device recall
Medtronic NDI Passive Spheres REF: 8801071, Sterile EO, 1/Tray 12 pk., Rxonly
- Recall number
- Z-0194-2027
- Event id
- 99895
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Medtronic Navigation, Inc.
- Report date
- Oct 28, 2026
- Posted
- Oct 16, 2026
- Initiated
- Aug 31, 2026
- Center classification date
- Oct 16, 2026
- Product code
- HAW
- Device type
- Neurological Stereotaxic Instrument
- 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.
- Root cause
- Under Investigation by firm
- Quantity
- 14210 units
- Code info
- UDI: 20805832070016/ Lot codes: 2506331 2506571 2510111 2510511 2511091
- 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,
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K033621
- Location
- Lafayette, CO, United States