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 2024-01-03; 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 SynchroMed II, Model 8637-40, Programmable pump

Name: FDA Recall Record — Medtronic Neuromodulation
Creator: Argus HQ
Published: 2024-01-03
License: https://argushq.ai/methodology

Event date: 2024-01-03 00:00:00Z
Observed: 2026-07-16 23:20:08Z
Source ID: Z-0615-2024
Payload hash: bbb98aa094104988f7147c69…

Summary

Medtronic recently identified that if the SynchroMed II pump switches into telemetry mode due to electromagnetic interference (EMI) from an MRI scan, while the pump is sounding an alarm, the pump will not resume drug delivery after leaving the MRI magnetic field, which is inconsistent with the curre… 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 2024-01-03; 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 SynchroMed II, Model 8637-40, Programmable pump. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-medtronic-neuromodulation-z-0615-2024

MLA

"Medtronic Neuromodulation — Class II recall: Medtronic SynchroMed II, Model 8637-40, Programmable pump." Argus HQ Research, Digital Empire Holdings LLC, 2024, argushq.ai/events/fda-recall-medtronic-neuromodulation-z-0615-2024.

Chicago

Argus HQ Research. "Medtronic Neuromodulation — Class II recall: Medtronic SynchroMed II, Model 8637-40, Programmable pump." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-medtronic-neuromodulation-z-0615-2024.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_medtronic_neuromodulation_z_0615_2024_2024,
  title = {Medtronic Neuromodulation — Class II recall: Medtronic SynchroMed II, Model 8637-40, Programmable pump},
  author = {{Argus HQ Research}},
  year = {2024},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-medtronic-neuromodulation-z-0615-2024},
  note = {Accessed: July 23, 2026}
}

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