FDA action counts
| Total FDA actions | 3 |
|---|---|
| Warning letters | 0 |
| Recalls | 3 |
| Approval records | 0 |
| Form 483 inspection citations | 0 |
| Most recent action | June 3, 2026 |
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?
- 3 total: 0 warning letters, 3 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, 3 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.
Every FDA action tied to this company, the week it happens.
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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… →
Compare with
Two different companies merged onto this page by mistake? Or a name variant missing? Tell us — corrections@argushq.ai
Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). Medtronic Neuromodulation — FDA Compliance Timeline. Digital Empire LLC. Retrieved from https://argushq.ai/company/medtronic-neuromodulation
"Medtronic Neuromodulation — FDA Compliance Timeline." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/company/medtronic-neuromodulation.
Argus HQ Research. "Medtronic Neuromodulation — FDA Compliance Timeline." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/company/medtronic-neuromodulation.
@misc{argushq_argushq_ai_company_medtronic_neuromodulation_2026,
title = {Medtronic Neuromodulation — FDA Compliance Timeline},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/company/medtronic-neuromodulation},
note = {Accessed: July 13, 2026}
}Source: FDA.gov (aggregated across Warning Letters, Recalls, Approvals, Form 483s) ↗

