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.
During non-axial/some axial exams, software anomalies occur during procedures affecting depth gauge graphic displays for cranial biopsy; causing displays to no longer synchronize with other navigational information showing inaccurate values, which may result in prolonged/additional procedure, tissue injury
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.
During certain types of cranial exams, the software may display incorrect depth measurements. This can cause the navigation system to show inaccurate values, leading to prolonged procedures or tissue injury if the surgeon relies on the incorrect readings.
Surgeons and medical staff using Medtronic StealthStation S7/i7 systems with the recalled software versions are most at risk. Patients undergoing cranial biopsies with these systems may also be affected.
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.
Verify your StealthStation software version matches the recalled models listed in the product description.
Software versions 9735585/00763000631635, 9735586/00763000631765, and 9735587/00763000631826 are affected.
No, but you should check your software version to ensure it is not one of the recalled versions.
The software may show inaccurate depth measurements during cranial biopsies, which could lead to tissue injury or longer procedures.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1630-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1630-2023 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.
