Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Stealth S8 Clinical Software Application Recalled by Medtronic Navigation, Inc. Due to Due to a software issue, there is the...
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
Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures.
Quantity: 3286 applications.
Why Was This Recalled?
Due to a software issue, there is the potential for a missing digit, letter, or decimal in either the "distance to target" or "tip stop point" display during navigation.
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