StealthStation Cranial Software displays inaccurate navigation during brain surgery
A software anomaly in Medtronic's StealthStation Cranial Software may cause inaccurate surgical navigation during brain procedures. This can result in unintended tissue damage and prolonged surgery.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: FDA Class I medical device recall. The FDA's own classification as Class I establishes Critical severity per the recall rubric. Inaccurate surgical navigation during brain procedures poses direct risk to patient safety during critical neurosurgical procedures.
Plain-English summary
Medtronic Navigation, Inc. is recalling StealthStation Cranial Software (Model 9735585) used with StealthStation S7/i7 surgical navigation systems. This software guides surgeons during cranial procedures including tumor resection, shunt placement, and deep brain stimulation.
A software anomaly occurs in certain surgical configurations when surgeons use nonaxial or some axial exams with a surgical plan, Target Guidance selected, tip projection utilized, and Navigate Projection enabled. Under these conditions, distance measurements displayed by the software become desynchronized from the actual navigational information, causing inaccurate values to appear on screen during the procedure.
This misalignment may result in unintended tissue damage and prolonged surgical procedures. Because the software provides critical real-time guidance during neurosurgery, inaccurate navigation could compromise surgical precision and patient safety.
The recall affects 556 units distributed in the United States and internationally. Healthcare facilities should contact Medtronic for instructions on verification and corrective action. The recalled software versions are 3.1.1, 3.1.2, and 3.1.3.
The recalled product
- Product
- StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems
- Manufacturer
- Medtronic Navigation, Inc.
- Hazard
- inaccurate-navigation
- tissue-injury
- surgical-guidance-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Model/UDI-DI/Software Versions: 9735585/00763000253165
- 00763000306762 (inside Kits: 00763000299927
- 00763000299972)
- 00763000517267(inside Kits: 00763000517274
- 00763000517335)/v3.1.1
- 3.1.2
- and 3.1.3
Distribution
Distributed in 1 state:
- PR
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