Medtronic StealthStation Cranial Software Recall for Biopsy Depth Gauge Error
Medtronic is recalling StealthStation Cranial and Synergy Cranial software due to an incorrect display of the Biopsy Depth Gauge that resulted in the biopsy of healthy tissue.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classified this as a Class I recall, which mandates a severity score of 5 per the rubric, as it involves a reasonable probability of serious adverse health consequences or death.
Plain-English summary
Medtronic Navigation, Inc. is recalling the StealthStation Cranial and Synergy Cranial software, specifically the Optical Pocket Guide and Biopsy Needle Kit accessories. The recall involves 5,487 impacted systems distributed across the United States and numerous international locations.
The recall was initiated because of an incorrect display of the Biopsy Depth Gauge graphical representation in the Guidance View using Cranial software. This error resulted in the biopsy of healthy tissue. The affected software versions include 2.2.0, 2.2.5, 2.2.6, and 2.2.7 for Synergy Cranial, and 3.0.0, 3.0.1, 3.0.2, and 3.1.0 for StealthStation S7 Cranial.
Healthcare facilities and users of these systems should contact Medtronic Navigation, Inc. for instructions on how to resolve the issue. The agency has classified this as a Class I recall.
The recalled product
- Product
- StealthStation Cranial and Synergy Cranial Depth Gauge: StealthStation Cranial Optical Pocket Guide - Instructions for cranial procedures using optical localization StealthStation Cranial version 3.0, 3.1 CE 0344 Rx Only 2018-02 9735489 Revision 3 Medtronic Navigation, Inc.…
- Manufacturer
- Medtronic Navigation, Inc.
- Affected units
- 5,487
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)
- 2.2.5
- 2.2.6
- 2.2.7 Synergy Cranial 9735585 3.0.0
- 3.0.1
- 3.0.2
- 9733763
- 9731975
Distribution
Related recalls
Same manufacturer · Medtronic Navigation, Inc.
See all →- HighMedtronic Percutaneous Reference Pins May Not Fit Properly
FDA (Devices) · 2025-02-05
- HighStealthStation S8 Spine Surgery Navigation System Recalled for Software Defects
FDA (Devices) · 2024-10-16
- SevereStealth S8 neurosurgical navigation software display error affecting surgical guidance
FDA (Devices) · 2024-05-15
- HighMedtronic Percutaneous Pins Recalled for Potential Fitting and Removal Issues
FDA (Devices) · 2024-01-17
- HighMedtronic Percutaneous Surgical Pins Recalled Due to Potential Fitting Defects
FDA (Devices) · 2024-01-17
Same hazard · software error
See all →- ModerateBeckman Coulter DxC 500 AU Clinical Chemistry Analyzers Recalled for Software Error
FDA (Devices) · 2026-10-14
- HighPhilips Spectral CT 7500 Software Recall for Radiation Exposure Risk
FDA (Devices) · 2026-10-07
- HighBard EnCor EnCompass Breast Biopsy System Software Recall
FDA (Devices) · 2026-10-07
- ModerateBeckman Coulter AU480 Chemistry Analyzer Software Error Recall
FDA (Devices) · 2026-10-07
- HighPhilips EPIQ Elite Ultrasound System Recalled for Software Error
FDA (Devices) · 2026-09-30
Similar recalls
- SevereStealthstation and Synergy Cranial surgical navigation system software synchronization error
FDA (Devices) · 2021-12-29
- CriticalStealthStation Cranial Software displays inaccurate navigation during brain surgery
FDA (Devices) · 2023-06-14
- SevereStealthStation Cranial Software Depth Gauge Synchronization Failure Risk
FDA (Devices) · 2023-06-14
- ModerateMedtronic Navigation Recalls Synergy Cranial S7 Software Applications
FDA (Devices) · 2016-08-10
- ModerateMedtronic StealthStation Software Recalled Due to Scanner Compatibility Issues
FDA (Devices) · 2016-08-10
- HighStealthStation S8 Spine Surgery Navigation System Recalled for Software Defects
FDA (Devices) · 2024-10-16