Has Medtronic Neuromodulation had other FDA enforcement actions?

Yes. Argus HQ has recorded 36 total FDA actions tied to Medtronic Neuromodulation: 0 warning letters, 36 recalls, 0 approval records, and 0 Form 483 inspection citations.

What kind of FDA record is this?

This is an Argus HQ record of a FDA Recall, tagged high severity by Argus HQ. FDA published the underlying record on 2024-10-30; Argus observed and indexed it on 2026-07-16.

Where can I verify this record directly with FDA?

The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

.hq

fda_recall · device_recall · high

Medtronic Neuromodulation — Class II recall: Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.

Name: FDA Recall Record — Medtronic Neuromodulation
Creator: Argus HQ
Published: 2024-10-30
License: https://argushq.ai/methodology

Event date: 2024-10-30 00:00:00Z
Observed: 2026-07-16 23:20:08Z
Source ID: Z-0206-2025
Payload hash: 81db089e2e01335f4bbea91d…

Summary

A limited number of Percept RC Implantable Neurostimulators (INS), Model B35300 will not be able to communicate with the A610 DBS Clinician Programmer Application upon use and an "Invalid Device" message will appear. Status: Ongoing.

Entities

Medtronic Neuromodulation

View source record ↗

Frequently asked questions

Has Medtronic Neuromodulation had other FDA enforcement actions?: Yes. Argus HQ has recorded 36 total FDA actions tied to Medtronic Neuromodulation: 0 warning letters, 36 recalls, 0 approval records, and 0 Form 483 inspection citations.
What kind of FDA record is this?: This is an Argus HQ record of a FDA Recall, tagged high severity by Argus HQ. FDA published the underlying record on 2024-10-30; Argus observed and indexed it on 2026-07-16.
Where can I verify this record directly with FDA?: The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

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.

APA

Argus HQ Research (2024). Medtronic Neuromodulation — Class II recall: Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-medtronic-neuromodulation-z-0206-2025

MLA

"Medtronic Neuromodulation — Class II recall: Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.." Argus HQ Research, Digital Empire Holdings LLC, 2024, argushq.ai/events/fda-recall-medtronic-neuromodulation-z-0206-2025.

Chicago

Argus HQ Research. "Medtronic Neuromodulation — Class II recall: Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-medtronic-neuromodulation-z-0206-2025.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_medtronic_neuromodulation_z_0206_2025_2024,
  title = {Medtronic Neuromodulation — Class II recall: Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.},
  author = {{Argus HQ Research}},
  year = {2024},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-medtronic-neuromodulation-z-0206-2025},
  note = {Accessed: July 23, 2026}
}

Informational only. Not legal, financial, or medical advice.