Medtronic Neuromodulation — FDA Compliance Timeline

FDA action counts

Enforcement history

On 2026-05-20, Argus HQ recorded a FDA recall for Medtronic Neuromodulation, rated "high" severity in Argus HQ's classification: Medtronic Neuromodulation — Class II recall: Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software App… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-06-03, Argus HQ recorded a FDA recall for Medtronic Neuromodulation, rated "high" severity in Argus HQ's classification: Medtronic Neuromodulation — Class II recall: Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimul… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-06-03, Argus HQ recorded a FDA recall for Medtronic Neuromodulation, rated "high" severity in Argus HQ's classification: Medtronic Neuromodulation — Class II recall: Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Stimul… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. In total, Medtronic Neuromodulation has 3 FDA events on file with Argus HQ across the sources Argus HQ currently tracks (FDA Warning Letters, recalls, drug/biologic approvals, and Form 483 inspection observations). 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 Neuromodulation has 3 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.

Frequently asked questions

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

36 total: 0 warning letters, 36 recalls, 0 approval records, and 0 Form 483 inspection citations.

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

June 3, 2026. Argus HQ ingests new FDA enforcement records daily.

Has Medtronic Neuromodulation had product recalls?

Yes, 36 recalls on file. See the full history below for each one.

Is this FDA enforcement data for Medtronic Neuromodulation 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 Neuromodulation — Class II recall: Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimul… →
• Medtronic Neuromodulation — Class II recall: Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Stimul… →
• Medtronic Neuromodulation — Class II recall: Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software App… →
• Medtronic Neuromodulation — Class II recall: A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.… →
• Medtronic Neuromodulation — Class II recall: Restore Clinician Programmer Application (CP App), Model A71100 used with the fo… →
• Medtronic Neuromodulation — Class II recall: Enhanced Verify Evaluation Handset (CFN HH90130FA) →
• Medtronic Neuromodulation — Class II recall: Stimulation RC Clinician Programmer Application, Model A71400, when used with th… →
• Medtronic Neuromodulation — Class II recall: A820 myPTM Software Application associated with Medtronic SynchroMed Pump and In… →
• Medtronic Neuromodulation — Class II recall: SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used wi… →
• Medtronic Neuromodulation — Class II recall: SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used wi… →

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