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Use caution Medical device recall · FDA · Published April 11, 2023

Medtronic StealthStation Cranial Software Recall: Inaccurate Depth Displays Risk Tissue

Medtronic recalls specific StealthStation Cranial Software versions used with S7/i7 systems due to inaccurate depth displays during cranial biopsies, potentially causing tissue injury. Affected models include 9735585, 9735586, and 9735587 kits.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1630-2023Medical deviceMedtronic ›
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Contact the company

Recalling firmMedtronic Navigation, Inc.200 Medtronic Drive · Lafayette, CO 80026
✎ GovInfoNow plain-language explainer

Medtronic is recalling specific versions of its StealthStation Cranial Software for use with S7/i7 systems. The software may show inaccurate depth measurements during cranial biopsies, which could lead to tissue injury or longer procedures. This affects surgeons and medical staff using these systems. Read more at govinfonow.com/recall/58587-medtronic-stealthstation-cranial-software-recall-inaccurate-depth-displays-risk-tissue.

Source Summary by GovInfoNow · govinfonow.com/recall/58587-medtronic-stealthstation-cranial-software-recall-inaccurate-depth-displays-risk-tissue · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1630-2023

Cite this page

“Medtronic StealthStation Cranial Software Recall: Inaccurate Depth Displays Risk Tissue.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58587-medtronic-stealthstation-cranial-software-recall-inaccurate-depth-displays-risk-tissue. Based on FDA recall #Z-1630-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1630-2023%22&limit=1).

The FDA announced on April 11, 2023, that Medtronic Navigation, Inc. is recalling StealthStation Cranial Software models 9735585, 9735586, and 9735587 due to software anomalies that may cause inaccurate depth gauge displays during cranial biopsy procedures.

How to tell if you have it

  • Brand: Medtronic
  • Product: StealthStation Cranial Software
  • Models: 9735585, 9735586 (kit), 9735587 (kit)
  • Compatible Systems: StealthStation S7/i7 systems
  • Software Versions: 9735585/00763000631635, 9735586/00763000631765, 9735587/00763000631826; 3.1.4
  • Units Affected: 746

The hazard

According to the FDA, software anomalies during non-axial or some axial exams may cause depth gauge graphic displays for cranial biopsy to no longer synchronize with other navigational information. This results in inaccurate values which may lead to prolonged or additional procedures and tissue injury.

Context

GovInfoNow's records show Medtronic Navigation, Inc. has issued 25 other recalls since June 7, 2017. Recent brand-specific recalls include a December 4, 2024 notice for PIN surgical pins that may not fit patient reference frames and an August 22, 2024 recall for StealthStation S8 App software issues causing flipped images. Other recent recalls of similar products include the Howmedica Stryker CranialMask Tracker software error (November 12, 2025), the Canon Vantage Galan 3T medical device electrode distance risk (October 16, 2025), and the Medtronic Vanta CP App software recall for prolonged surgery risk (December 3, 2025).

How to tell if you have this one

Check if your StealthStation S7/i7 system has software version 9735585/00763000631635, 9735586/00763000631765, or 9735587/00763000631826. The software versions are part of the 3.1.4 release.

  • Brand
    Medtronic
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Software Version

    Verify your StealthStation software version matches the recalled models listed in the product description.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 42 states.

Alaska: named in the noticeAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: nationwideIDMontana: named in the noticeMTNorth Dakota: named in the noticeNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: named in the noticeWYSouth Dakota: named in the noticeSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: nationwideSCDistrict of Columbia: named in the noticeDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “Worldwide Distibution: US (nationwide): OH, IL, CA, MI, FL, LA, OK, WA, AR, NJ, MN, MO, WI, MA, ND, NY, MD, OR, AK, NE, TN, AZ, IN, GA, GU, VA, PA, TX, SD, MT, NV, MS, KY, AL, CT, WV, KS, IA, NC, UT, CO, NH, DC, WY. OUS (foreign): ALBANIA,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 2 months after the firm started it.

1. Firm started the recall: Apr 11, 202312. FDA classified it Class I: Jun 2, 202323. Published in FDA’s Enforcement Report: Jun 14, 202332023
  1. Firm started the recall
  2. FDA classified it Class I
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

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-1630-2023 (April 11, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1630-2023 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA