FDA recall record · openFDA

Medtronic Navigation, Inc.

8 FDA recalls on record (2023–2024) — 8 device. 8 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Their is the potential that the percutaneous pin may have a cross-pin that may render the pin unable to fit into tap cap 2

Due to two software anomalies that can occur within a spine procedure. Two issues are: 1. Navigation Orientation - whe 1

Due to an increase in complaint that the percutaneous reference pin would not fit into the patient reference frame or pe 1

During non-axial/some axial exams, software anomalies occur during procedures affecting depth gauge graphic displays for 1

In nonaxial/some axial exams if surgical plan utilized, Target Guidance selected, tip projection utilized, Navigate Proj 1

Recalls

Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid fo Class I 2024-03-26 StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems Class I 2023-04-11 StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems Class I 2023-04-11 StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The StealthStation System, with StealthStation Cra Class I 2023-09-27 StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spin Class II 2024-08-22 Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150MM, STERILE PERCUTANEOUS REF: 97733236 Th Class II 2024-12-04 Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS Class II 2023-11-28 Medtronic, REF 9733236, Pin, 150mm, STERILE, PERCUTANEOUS Class II 2023-11-28

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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