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 high severity by Argus HQ. FDA published the underlying record on 2024-10-16; 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 · high

Medtronic Navigation, Inc. — Class II recall: StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The Stealth…

Name: FDA Recall Record — Medtronic Navigation, Inc.
Creator: Argus HQ
Published: 2024-10-16
License: https://argushq.ai/methodology

Event date: 2024-10-16 00:00:00Z
Observed: 2026-07-16 23:20:08Z
Source ID: Z-0050-2025
Payload hash: dbe4d8f1a89a6552ec0b92d8…

Summary

Due to two software anomalies that can occur within a spine procedure. Two issues are: 1. Navigation Orientation - when lateral orientation radiographic images are taken, information may appear flipped when utilizing the system (180 degree flipped). 2. Pop-up Message - when using CT+Fluouroscopy… 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 high severity by Argus HQ. FDA published the underlying record on 2024-10-16; 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 (2024). Medtronic Navigation, Inc. — Class II recall: StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762)    The Stealth…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-medtronic-navigation-inc-z-0050-2025

MLA

"Medtronic Navigation, Inc. — Class II recall: StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762)    The Stealth…." Argus HQ Research, Digital Empire Holdings LLC, 2024, argushq.ai/events/fda-recall-medtronic-navigation-inc-z-0050-2025.

Chicago

Argus HQ Research. "Medtronic Navigation, Inc. — Class II recall: StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762)    The Stealth…." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-medtronic-navigation-inc-z-0050-2025.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_medtronic_navigation_inc_z_0050_2025_2024,
  title = {Medtronic Navigation, Inc. — Class II recall: StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762)    The Stealth…},
  author = {{Argus HQ Research}},
  year = {2024},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-medtronic-navigation-inc-z-0050-2025},
  note = {Accessed: July 23, 2026}
}

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