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 2025-12-31; 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: Restore Clinician Programmer Application (CP App), Model A71100 used with the fo…

Name: FDA Recall Record — Medtronic Neuromodulation
Creator: Argus HQ
Published: 2025-12-31
License: https://argushq.ai/methodology

Event date: 2025-12-31 00:00:00Z
Observed: 2026-07-16 23:20:07Z
Source ID: Z-0996-2026
Payload hash: 213d1f57fa67309b426ba94b…

Summary

Software issue where a Device Reset message displayed on the app was unable to be cleared. In rare cases, this resulted in an inability to resume therapy, and the patient experienced a recurrence of underlying pain symptoms. Resolution would require surgical replacement of the INS. 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 2025-12-31; 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 (2025). Medtronic Neuromodulation — Class II recall: Restore Clinician Programmer Application (CP App), Model A71100 used with the fo…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-medtronic-neuromodulation-z-0996-2026

MLA

"Medtronic Neuromodulation — Class II recall: Restore Clinician Programmer Application (CP App), Model A71100 used with the fo…." Argus HQ Research, Digital Empire Holdings LLC, 2025, argushq.ai/events/fda-recall-medtronic-neuromodulation-z-0996-2026.

Chicago

Argus HQ Research. "Medtronic Neuromodulation — Class II recall: Restore Clinician Programmer Application (CP App), Model A71100 used with the fo…." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-medtronic-neuromodulation-z-0996-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_medtronic_neuromodulation_z_0996_2026_2025,
  title = {Medtronic Neuromodulation — Class II recall: Restore Clinician Programmer Application (CP App), Model A71100 used with the fo…},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-medtronic-neuromodulation-z-0996-2026},
  note = {Accessed: July 23, 2026}
}

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