Has Medtronic Neurosurgery had other FDA enforcement actions?

Yes. Argus HQ has recorded 9 total FDA actions tied to Medtronic Neurosurgery: 0 warning letters, 9 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 critical severity by Argus HQ. FDA published the underlying record on 2024-12-25; 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 · critical

Medtronic Neurosurgery — Class I recall: Exacta External Drainage and Monitoring System: 27581 KIT 27581 EXACTA W/EDM VC…

Name: FDA Recall Record — Medtronic Neurosurgery
Creator: Argus HQ
Published: 2024-12-25
License: https://argushq.ai/methodology

Event date: 2024-12-25 00:00:00Z
Observed: 2026-07-16 23:20:07Z
Source ID: Z-0662-2025
Payload hash: a8b061dbe455388ccae281d0…

Summary

Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS). Status: Ongoing.

Entities

Medtronic Neurosurgery

View source record ↗

Frequently asked questions

Has Medtronic Neurosurgery had other FDA enforcement actions?: Yes. Argus HQ has recorded 9 total FDA actions tied to Medtronic Neurosurgery: 0 warning letters, 9 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 critical severity by Argus HQ. FDA published the underlying record on 2024-12-25; 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 Neurosurgery — Class I recall: Exacta External Drainage and Monitoring System:  27581 KIT 27581 EXACTA W/EDM VC…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-medtronic-neurosurgery-z-0662-2025

MLA

"Medtronic Neurosurgery — Class I recall: Exacta External Drainage and Monitoring System:  27581 KIT 27581 EXACTA W/EDM VC…." Argus HQ Research, Digital Empire Holdings LLC, 2024, argushq.ai/events/fda-recall-medtronic-neurosurgery-z-0662-2025.

Chicago

Argus HQ Research. "Medtronic Neurosurgery — Class I recall: Exacta External Drainage and Monitoring System:  27581 KIT 27581 EXACTA W/EDM VC…." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-medtronic-neurosurgery-z-0662-2025.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_medtronic_neurosurgery_z_0662_2025_2024,
  title = {Medtronic Neurosurgery — Class I recall: Exacta External Drainage and Monitoring System:  27581 KIT 27581 EXACTA W/EDM VC…},
  author = {{Argus HQ Research}},
  year = {2024},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-medtronic-neurosurgery-z-0662-2025},
  note = {Accessed: July 23, 2026}
}

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