What is the most recent FDA action against Medtronic Navigation, Inc.?

The most recent FDA event Argus HQ has on file for Medtronic Navigation, Inc. is dated 2025-02-05, with a severity rating of "critical" in Argus HQ's classification. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

Does Argus HQ track new FDA actions for Medtronic Navigation, Inc. automatically?

Yes. Argus HQ ingests FDA sources daily, including FDA warning letters, recalls, drug and biologic approvals, and Form 483 inspection observations. When a new FDA action linked to Medtronic Navigation, Inc. is observed, this page's event count and history update automatically.

How many FDA actions does Argus HQ track for Medtronic Navigation, Inc.?

10 total: 0 warning letters, 10 recalls, 0 approval records, and 0 Form 483 inspection citations.

What is the most recent FDA action on file for Medtronic Navigation, Inc.?

February 5, 2025. Argus HQ ingests new FDA enforcement records daily.

FDA Enforcement History: Medtronic Navigation, Inc.

Here's the summary: Argus HQ has recorded 10 FDA events for Medtronic Navigation, Inc.: 0 warning letters, 10 recalls, 0 approvals, and 0 inspection 483 observations. These events span from 2023-01-18 to 2025-02-05. The most severe rating Argus HQ has assigned across this history is "critical". Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed.

FDA action counts

Total FDA actions	10
Warning letters	0
Recalls	10
Approval records	0
Form 483 inspection citations	0
Most recent action	February 5, 2025

Enforcement history

On 2025-02-05, Argus HQ recorded an FDA recall for Medtronic Navigation, Inc., rated "high" severity in Argus HQ's classification: Medtronic Navigation, Inc. — Class II recall: Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150MM,…. On 2024-10-16, Argus HQ recorded an FDA recall for Medtronic Navigation, Inc., rated "high" severity in Argus HQ's classification: Medtronic Navigation, Inc. — Class II recall: StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The Stealth…. On 2024-05-15, Argus HQ recorded an FDA recall for Medtronic Navigation, Inc., rated "critical" severity in Argus HQ's classification: Medtronic Navigation, Inc. — Class I recall: Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used i…. On 2024-01-17, Argus HQ recorded an FDA recall for Medtronic Navigation, Inc., rated "high" severity in Argus HQ's classification: Medtronic Navigation, Inc. — Class II recall: Medtronic, REF 9733236, Pin, 150mm, STERILE, PERCUTANEOUS. On 2024-01-17, Argus HQ recorded an FDA recall for Medtronic Navigation, Inc., rated "high" severity in Argus HQ's classification: Medtronic Navigation, Inc. — Class II recall: Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS. On 2023-11-15, Argus HQ recorded an FDA recall for Medtronic Navigation, Inc., rated "critical" severity in Argus HQ's classification: Medtronic Navigation, Inc. — Class I recall: StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The Stealt…. On 2023-06-14, Argus HQ recorded an FDA recall for Medtronic Navigation, Inc., rated "critical" severity in Argus HQ's classification: Medtronic Navigation, Inc. — Class I recall: StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit),…. On 2023-06-14, Argus HQ recorded an FDA recall for Medtronic Navigation, Inc., rated "critical" severity in Argus HQ's classification: Medtronic Navigation, Inc. — Class I recall: StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7…. On 2023-02-08, Argus HQ recorded an FDA recall for Medtronic Navigation, Inc., rated "high" severity in Argus HQ's classification: Medtronic Navigation, Inc. — Class II recall: AxiEM" Non-Invasive Patient Tracker. On 2023-01-18, Argus HQ recorded an FDA recall for Medtronic Navigation, Inc., rated "high" severity in Argus HQ's classification: Medtronic Navigation, Inc. — Class II recall: RadiaLux Lighted Retractor (Pink), REF: 50-101-1.

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. Medtronic Navigation, Inc. has 10 separate FDA recalls on file, more than a single isolated recall event. A pattern across multiple FDA touchpoints does not by itself establish that any specific product currently poses a risk; it reflects only the frequency of FDA engagement with this company as recorded in Argus HQ's database. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ does not independently verify FDA's underlying findings; this page summarizes what FDA has published and links back to the original FDA source for each event. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

Frequently asked questions

What is the most recent FDA action against Medtronic Navigation, Inc.?: The most recent FDA event Argus HQ has on file for Medtronic Navigation, Inc. is dated 2025-02-05, with a severity rating of "critical" in Argus HQ's classification. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.
Does Argus HQ track new FDA actions for Medtronic Navigation, Inc. automatically?: Yes. Argus HQ ingests FDA sources daily, including FDA warning letters, recalls, drug and biologic approvals, and Form 483 inspection observations. When a new FDA action linked to Medtronic Navigation, Inc. is observed, this page's event count and history update automatically.
How many FDA actions does Argus HQ track for Medtronic Navigation, Inc.?: 10 total: 0 warning letters, 10 recalls, 0 approval records, and 0 Form 483 inspection citations.
What is the most recent FDA action on file for Medtronic Navigation, Inc.?: February 5, 2025. Argus HQ ingests new FDA enforcement records daily.

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

Verified from FDA.gov · Last updated: Feb 5, 2025

Cite this record

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

APA

Argus HQ Research (2025). FDA Enforcement History: Medtronic Navigation, Inc.. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/company/medtronic-navigation-inc

MLA

"FDA Enforcement History: Medtronic Navigation, Inc.." Argus HQ Research, Digital Empire Holdings LLC, 2025, argushq.ai/company/medtronic-navigation-inc.

Chicago

Argus HQ Research. "FDA Enforcement History: Medtronic Navigation, Inc.." Digital Empire Holdings LLC. Accessed July 17, 2026. https://argushq.ai/company/medtronic-navigation-inc.

BibTeX

@misc{argushq_argushq_ai_company_medtronic_navigation_inc_2025,
  title = {FDA Enforcement History: Medtronic Navigation, Inc.},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/company/medtronic-navigation-inc},
  note = {Accessed: July 17, 2026}
}

Source: FDA.gov (aggregated across Warning Letters, Recalls, Approvals, Form 483s) ↗