Medtronic, Inc. — FDA Enforcement History

FDA action counts

Enforcement history

On 2026-05-06, Argus HQ recorded an FDA recall for Medtronic, Inc., rated "high" severity in Argus HQ's classification: Medtronic, Inc. — Class II recall: Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, car…. 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, Inc. 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.

Frequently asked questions

Is this FDA enforcement data for Medtronic, Inc. 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.

How many FDA actions has Medtronic, Inc. had?

Argus HQ has recorded 1 FDA events for Medtronic, Inc.: 0 warning letters, 1 recalls, 0 approvals, and 0 Form 483 inspection observations. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

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

The most recent FDA event Argus HQ has on file for Medtronic, Inc. is dated 2026-05-06, with a severity rating of "high" 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, 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, Inc. is observed, this page's event count and history update automatically.

Related enforcement actions

• Medtronic, Inc. — Class II recall: Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, car… →
• Medtronic Inc — Class II recall: Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G1210009… →
• Medtronic, Inc. — Class II recall: Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable car… →
• Medtronic, Inc. — Class II recall: Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the follow… →
• Medtronic, Inc. — Class II recall: Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the foll… →
• Medtronic, Inc. — Class II recall: Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number… →
• Medtronic, Inc. — Class II recall: Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model… →
• Medtronic, Inc. — Class II recall: Azure S DR MRI SureScan, Product number W3DR01 →
• Medtronic Inc. — Class II recall: 2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product… →
• Medtronic Inc. — Class II recall: COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2QQ, Implantable Cardiove… →

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