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
Medtronic is recalling StealthStation Cranial Software version 3.1.1 to 3.1.3 used with StealthStation S7/i7 systems. This software may display inaccurate navigation during certain brain surgeries, potentially causing tissue injury or longer procedures.
During nonaxial or some axial exams, if specific surgical settings are used, the software may show inaccurate navigation information. This could lead to incorrect tissue targeting during brain surgery, potentially causing tissue injury or requiring longer procedures.
Surgical teams using Medtronic StealthStation S7/i7 systems with the recalled software versions are affected. Patients undergoing brain surgery with this specific software version are at risk of tissue injury.
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).
Verify the software version on your StealthStation Cranial Software by checking the model number and version codes listed in the recall notice.
Yes, during specific surgical procedures, the software may display inaccurate navigation information, which could lead to tissue injury or longer surgery times.
Software versions 3.1.1, 3.1.2, and 3.1.3 with model number 9735585 are affected.
No, but you should check your software version and contact Medtronic if you have the affected versions.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1666-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1666-2023 from Medtronic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
