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fda_recall · device_recall · high

Medtronic Neurosurgery — Class II recall: Ventriculostomy Kit, REF: 46154

Event date
2026-07-29 00:00:00Z
Observed
2026-08-04 04:20:52Z
Source ID
Z-2768-2026
Payload hash
720e22fb13b9c137c4e02cb6

Summary

Ventriculostomy devices, used during ventriculostomy procedures to gain access to the ventricular system, may exhibit endotoxin levels that exceed the acceptable limit for devices that come into contact with cerebrospinal fluid; endotoxin exposure can cause an acute inflammatory process. Status: Ongoing.

Frequently asked questions

Has Medtronic Neurosurgery had other FDA enforcement actions?
Yes. Argus HQ has recorded 10 total FDA actions tied to Medtronic Neurosurgery: 0 warning letters, 10 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 2026-07-29; Argus observed and indexed it on 2026-08-04.
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 (2026). Medtronic Neurosurgery — Class II recall: Ventriculostomy Kit, REF: 46154. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-medtronic-neurosurgery-z-2768-2026
MLA
"Medtronic Neurosurgery — Class II recall: Ventriculostomy Kit, REF: 46154." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-medtronic-neurosurgery-z-2768-2026.
Chicago
Argus HQ Research. "Medtronic Neurosurgery — Class II recall: Ventriculostomy Kit, REF: 46154." Digital Empire Holdings LLC. Accessed August 4, 2026. https://argushq.ai/events/fda-recall-medtronic-neurosurgery-z-2768-2026.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_medtronic_neurosurgery_z_2768_2026_2026,
  title = {Medtronic Neurosurgery — Class II recall: Ventriculostomy Kit, REF: 46154},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-medtronic-neurosurgery-z-2768-2026},
  note = {Accessed: August 4, 2026}
}

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