Recall Z-0194-2027 ยท HAW Neurological Stereotaxic Instrument
Medtronic Navigation, Inc.
Medtronic NDI Passive Spheres REF: 8801071, Sterile EO, 1/Tray 12 pk., Rxonly
| Date | Oct 16, 2026 (initiated Aug 31, 2026) |
| Status | Open, Classified |
| 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 |
| Action | On September 11, 2026 Medtronic Navigation Inc. issued a Urgent Medical Device Recall notification email. Medtronic ask consignees to take the following actions: 1. Immediately locate and quarantine all unused impacted product(s).; 2. Return unused impacted product(s) to Medtronic following the instructions in the enclosed Customer Confirmation Form.; 3. Complete the Customer Confirmation Form enclosed with this letter, acknowledging that you have received this information, and email the completed form to Medtronic at neuro.quality@medtronic.com.; 4. If the affected devices have already been |
| Quantity | 14210 units |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033621 | NDI PASSIVE SPHERES Northern Digital, Inc., Jan 27, 2004 |