Agency classClass IOur severity:Critical FDA (Devices)·Z-1666-2023·Announced 2023-06-14

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.

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: 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.
Category: Medical Device — Surgical Navigation / Intraoperative Guidance
Hazard: inaccurate-navigation
tissue-injury
surgical-guidance-error
Affected units: 556

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:

Same manufacturer · Medtronic Navigation, Inc.

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Same hazard · inaccurate navigation