Has Medtronic Navigation, Inc. had other FDA enforcement actions?

Yes. Argus HQ has recorded 10 total FDA actions tied to Medtronic Navigation, Inc.: 0 warning letters, 10 recalls, 0 approval records, and 0 Form 483 inspection citations.

What kind of FDA record is this?

This is an Argus HQ record of a FDA Recall, tagged critical severity by Argus HQ. FDA published the underlying record on 2023-06-14; Argus observed and indexed it on 2026-07-16.

Where can I verify this record directly with FDA?

The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

.hq

fda_recall · device_recall · critical

Medtronic Navigation, Inc. — Class I recall: StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7…

Name: FDA Recall Record — Medtronic Navigation, Inc.
Creator: Argus HQ
Published: 2023-06-14
License: https://argushq.ai/methodology

Event date: 2023-06-14 00:00:00Z
Observed: 2026-07-16 23:20:09Z
Source ID: Z-1666-2023
Payload hash: d346cb1a512234f8607de14c…

Summary

In nonaxial/some axial exams if surgical plan utilized, Target Guidance selected, tip projection utilized, Navigate Projection enabled, software anomaly may occur during tumor resection/shunt placement/deep brain stimulation, where distance to/past target text no longer synchronized with navigation… Status: Ongoing.

Entities

Medtronic Navigation, Inc.

View source record ↗

Frequently asked questions

Has Medtronic Navigation, Inc. had other FDA enforcement actions?: Yes. Argus HQ has recorded 10 total FDA actions tied to Medtronic Navigation, Inc.: 0 warning letters, 10 recalls, 0 approval records, and 0 Form 483 inspection citations.
What kind of FDA record is this?: This is an Argus HQ record of a FDA Recall, tagged critical severity by Argus HQ. FDA published the underlying record on 2023-06-14; Argus observed and indexed it on 2026-07-16.
Where can I verify this record directly with FDA?: The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2023). Medtronic Navigation, Inc. — Class I recall: StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-medtronic-navigation-inc-z-1666-2023

MLA

"Medtronic Navigation, Inc. — Class I recall: StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7…." Argus HQ Research, Digital Empire Holdings LLC, 2023, argushq.ai/events/fda-recall-medtronic-navigation-inc-z-1666-2023.

Chicago

Argus HQ Research. "Medtronic Navigation, Inc. — Class I recall: StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7…." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-medtronic-navigation-inc-z-1666-2023.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_medtronic_navigation_inc_z_1666_2023_2023,
  title = {Medtronic Navigation, Inc. — Class I recall: StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7…},
  author = {{Argus HQ Research}},
  year = {2023},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-medtronic-navigation-inc-z-1666-2023},
  note = {Accessed: July 23, 2026}
}

Informational only. Not legal, financial, or medical advice.