FDA Actions Against Medtronic MiniMed

FDA action counts

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. Medtronic MiniMed has 1 FDA event on file. 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.

Enforcement history

On 2023-01-11, Argus HQ recorded an FDA recall for Medtronic MiniMed, rated "high" severity in Argus HQ's classification: Medtronic MiniMed — Class II recall: Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Gua…. 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.

Frequently asked questions

How many FDA actions does Argus HQ track for Medtronic MiniMed?

1 total: 0 warning letters, 1 recall, 0 approval records, and 0 Form 483 inspection citations.

What is the most recent FDA action on file for Medtronic MiniMed?

January 11, 2023. Argus HQ ingests new FDA enforcement records daily.

Has Medtronic MiniMed had product recalls?

Yes, 1 recall on file. See the full history below for each one.

Is this FDA enforcement data for Medtronic MiniMed 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 MiniMed — Class II recall: Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Gua… →

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