Use cautionMedical device recall · FDA · Published April 11, 2023
Medtronic StealthStation Cranial Software Recall: Inaccurate Navigation During Surgery
Medtronic recalls StealthStation Cranial Software version 3.1.1-3.1.3 for potential inaccuracies during brain surgery, risking tissue injury. Affected units include specific model numbers and software versions.
In nonaxial/some axial exams if surgical plan utilized, Target Guidance selected, tip projection utilized, Navigate Projection enabled, software anomaly may occur during tumor resection/shunt placement/deep brain stimulation, where distance to/past target text no longer synchronized with navigation information, inaccurate value displayed; may result in prolonged/additional procedure, tissue injury
Take action
Contact the company
📍Recalling firmMedtronic Navigation, Inc.200 Medtronic Drive · Lafayette, CO 80026
“Medtronic StealthStation Cranial Software Recall: Inaccurate Navigation During Surgery.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58588-medtronic-stealthstation-cranial-software-recall-inaccurate-navigation-during-surgery. Based on FDA recall #Z-1666-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1666-2023%22&limit=1).
Medtronic Navigation, Inc. recalled StealthStation Cranial Software, Model 9735585, used with StealthStation S7/i7 systems due to a software anomaly that may display inaccurate navigation values during surgery, the FDA said on April 11, 2023.
How to tell if you have it
Brand: Medtronic
Product: StealthStation Cranial Software
Model: 9735585
Compatible Systems: StealthStation S7/i7
Software Versions: v3.1.1, 3.1.2, and 3.1.3
Units Affected: 556
The hazard
The software anomaly may occur during tumor resection, shunt placement, or deep brain stimulation when specific planning features are utilized, causing the distance to target text to no longer synchronize with navigation information. This inaccurate value displayed may result in prolonged or additional procedure time and potential tissue injury.
Context
GovInfoNow's records show Medtronic Navigation, Inc. has had 25 other recalls on record since June 7, 2017. Recent related issues include a Dec. 4, 2024, recall for Medtronic PIN surgical pins that may not fit patient reference frames and an Aug. 22, 2024, recall for StealthStation S8 App versions 1.3.0 and 1.3.2 due to software anomalies causing flipped images. Other recent recalls of similar products include the Howmedica Stryker CranialMask Tracker software error (Nov. 12, 2025), the Medtronic Vanta CP App Software recall (Dec. 3, 2025), and the GE Medical Systems Imactis CT-Navigation System recall (Feb. 3, 2026).
How to tell if you have this one
Check for model number 9735585 with software versions 3.1.1, 3.1.2, or 3.1.3. The software versions are listed as 00763000253165, 00763000306762, or 00763000517267 (inside kits: 00763000299927, 00763000299972, 00763000517274, 00763000517335).
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 StealthStation Cranial Software by checking the model number and version codes listed in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “US Distribution: PR. OUS (foreign) distribution: ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BOSNIA and HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CANARY ISLANDS, CHILE, Colombia COLOMBIA, C¿TE D'IVOIRE, CROATIA, CZECH REPUBLIC, DENMARK,…” 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 2 months 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-1666-2023 (April 11, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1666-2023 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.