FDA Actions Against Medtronic Navigation, Inc.-Littleton

FDA action counts

Enforcement history

On 2024-06-12, Argus HQ recorded an FDA recall for Medtronic Navigation, Inc.-Littleton, rated "high" severity in Argus HQ's classification: Medtronic Navigation, Inc.-Littleton — Class II recall: O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and 3D…. On 2023-08-30, Argus HQ recorded an FDA recall for Medtronic Navigation, Inc.-Littleton, rated "high" severity in Argus HQ's classification: Medtronic Navigation, Inc.-Littleton — Class II recall: The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopi…. 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. 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.

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. Medtronic Navigation, Inc.-Littleton has 2 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

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

2 total: 0 warning letters, 2 recalls, 0 approval records, and 0 Form 483 inspection citations.

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

June 12, 2024. Argus HQ ingests new FDA enforcement records daily.

Has Medtronic Navigation, Inc.-Littleton had product recalls?

Yes, 2 recalls on file. See the full history below for each one.

Is this FDA enforcement data for Medtronic Navigation, Inc.-Littleton official?

Every record links directly to its primary FDA.gov source. Argus HQ aggregates and structures public FDA data; the verbatim FDA record is always the source of truth.

Related enforcement actions

• Medtronic Navigation, Inc.-Littleton — Class II recall: O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and 3D… →
• Medtronic Navigation, Inc.-Littleton — Class II recall: The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopi… →

Compare with

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• Medtronic Navigation, Inc.-Littleton vs PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.