Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic NDI Passive Spheres

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Medtronic NDI Passive Spheressee related information
Date Initiated by FirmAugust 31, 2026
Date PostedOctober 16, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0195-2027
Recall Event ID 99895
510(K)NumberK033621 
Product Classification Neurological stereotaxic Instrument - Product Code HAW
ProductMedtronic NDI Passive Spheres REF: 8801074, Sterile EO, 4/Tray 12 Pk., Rxonly
Code Information UDI: 20805832070023/ Lot codes: 2503141 2503241 2503411 2503491 2504081 2504091 2504211 2504301 2504331 2505211 2505221 2505351 2505641 2505651 2505681 2506081 2506161 2506341 2506551 2506581 2509781 2509791 2509811 2510121 2510741 2510751 2511101 2511121 2511501 2511601
FEI Number 1000517638
Recalling Firm/
Manufacturer		 Medtronic Navigation, Inc.
200 Medtronic Dr
Lafayette CO 80026-3735
For Additional Information ContactMedtronic Technical
720-890-3200
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 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 utilized and/or discarded, we still ask that you complete and return the Customer Confirmation Form detailing that information.; 5. This notice needs to be passed on to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. Please maintain a copy of this notice in your records.; 6. If you purchase this product directly from NDI, please contact NDI for the list of impacted product and instructions for return: spheres-na@ndigital.com
Quantity in Commerce83,594 units
DistributionUS: 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,
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = HAW
-
-