Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
StealthStation Cranial Software Recalled by Medtronic Navigation, Inc. Due to During non-axial/some axial exams, software anomalies occur during...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic Navigation, Inc. directly.
Affected Products
StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems
Quantity: 746
Why Was This Recalled?
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
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Medtronic Navigation, Inc.
Medtronic Navigation, Inc. has 91 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report