Agency classClass IOur severity:Severe FDA (Devices)·Z-1776-2024·Announced 2024-05-15

Stealth S8 neurosurgical navigation software display error affecting surgical guidance

Medtronic's Stealth S8 surgical navigation software has a display bug that may omit digits, letters, or decimals from critical readings during brain surgery. FDA classified this as Class I due to serious potential surgical errors.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this medical device recall as Class I. Per the rubric, FDA Class I recalls must receive a minimum severity score of 4 (Severe), regardless of whether actual injuries have been reported. The software display defect affects critical surgical navigation during neurosurgery, creating serious potential for harm.

Plain-English summary

The Stealth S8 Clinical Software Application is used in the StealthStation System to help surgeons locate anatomical structures during open or minimally invasive brain surgery. A software defect can cause missing digits, letters, or decimal points in the display of "distance to target" or "tip stop point" during surgical navigation.

These display errors may prevent surgeons from seeing accurate distance and positioning information during procedures, potentially leading to surgical errors or patient harm.

Approximately 3,286 units of this software have been distributed worldwide, including across the United States, Puerto Rico, and more than 75 countries.

The FDA classified this as a Class I recall due to the potential for serious patient harm. Healthcare facilities using this software should contact Medtronic Navigation, Inc. for instructions on patched software versions or alternative solutions. Do not use the recalled software versions until updates are provided.

The recalled product

Product: 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.
Manufacturer: Medtronic Navigation, Inc.
Category: Medical Device — Surgical Navigation Software
Hazard: software-defect
display-error
data-accuracy
Affected units: 3,286

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 (8)

UDIs: 00763000234867
00763000125295
00763000063177
00643169865341/ Software Versions: 1.2.0
1.1.0
1.0.3
1.0.2
and 1.0.1.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · Medtronic Navigation, Inc.

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