Lower riskMedical device recall · FDA · Published March 26, 2024
Medtronic Stealth S8 Software May Show Missing Digits During Neurosurgery
Medtronic recalls Stealth S8 Clinical Software versions 1.0.1-1.2.0 for potential missing digits in navigation displays during neurosurgery. Affected units may cause navigation errors.
Due to a software issue, there is the potential for a missing digit, letter, or decimal in either the "distance to target" or "tip stop point" display during navigation.
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Contact the company
📍Recalling firmMedtronic Navigation, Inc.200 Medtronic Drive · Lafayette, CO 80026
“Medtronic Stealth S8 Software May Show Missing Digits During Neurosurgery.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/55710-medtronic-stealth-s8-software-may-show-missing-digits-during-neurosurgery. Based on FDA recall #Z-1776-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1776-2024%22&limit=1).
The FDA announced on March 26, 2024, that Medtronic Navigation, Inc. is recalling the Stealth S8 Clinical Software Application due to a software issue that may cause missing digits or decimals in navigation displays. This Class I recall affects 3,286 applications distributed worldwide.
Software Versions: 1.2.0, 1.1.0, 1.0.3, 1.0.2, and 1.0.1
The hazard
According to the FDA, a software issue creates the potential for a missing digit, letter, or decimal in either the "distance to target" or "tip stop point" display during navigation.
Context
GovInfoNow's records show Medtronic Navigation, Inc. has issued 25 other recalls since June 7, 2017. Other recent recalls include a December 4, 2024 recall of PIN surgical pins that may not fit patient reference frames and an August 22, 2024 recall of StealthStation S8 App versions 1.3.0 and 1.3.2 for software issues causing flipped images or missing warnings. A November 20, 2025 recall addressed a rare therapy disruption risk in the Medtronic Restore CP App Model A71100.
How to tell if you have this one
Check for software versions 1.0.1 through 1.2.0 on the Stealth S8 Clinical Software Application. The product is used with the StealthStation System for neurosurgery procedures and has specific UDIs: 00763000234867, 00763000125295, 00763000063177, 00643169865341.
Brand
Medtronic
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify the software version on your Stealth S8 Clinical Software Application to see if it is affected (1.0.1 through 1.2.0).
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution. US nationwide including Puerto Rico, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 50 days after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1776-2024 (March 26, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1776-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.