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 S8 Application version 2.0 and 2.0.1 (Part 9735762) The Recalled by Medtronic Navigation, Inc. Due to Due to a software anomaly which potentially could...
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 S8 Application version 2.0 and 2.0.1 (Part 9735762) The StealthStation System, with StealthStation Cranial software, is intended as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures. The StealthStation FlexENT System, with StealthStation ENT software, is intended as an aid for locating anatomical structures in either open or percutaneous ENT procedures.
Quantity: 5,240 affected systems
Why Was This Recalled?
Due to a software anomaly which potentially could result in the surgical planning data shifting to an unintended location.
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