Has Stryker Neurovascular had other FDA enforcement actions?

Yes. Argus HQ has recorded 14 total FDA actions tied to Stryker Neurovascular: 0 warning letters, 14 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 2024-06-05; 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

Stryker Neurovascular — Class II recall: Trevo NXT ProVue 3 x 32, US, Catalog: 90312 Kits: TREVO NXT 3X32+TRAK21 2-PA…

Name: FDA Recall Record — Stryker Neurovascular
Creator: Argus HQ
Published: 2024-06-05
License: https://argushq.ai/methodology

Event date: 2024-06-05 00:00:00Z
Observed: 2026-07-16 23:20:09Z
Source ID: Z-1905-2024
Payload hash: ffeea994fe36364f94ac6b40…

Summary

Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fe… Status: Ongoing.

Entities

Stryker Neurovascular

View source record ↗

Frequently asked questions

Has Stryker Neurovascular had other FDA enforcement actions?: Yes. Argus HQ has recorded 14 total FDA actions tied to Stryker Neurovascular: 0 warning letters, 14 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 2024-06-05; 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). Stryker Neurovascular — Class II recall: Trevo NXT ProVue 3 x 32, US, Catalog: 90312    Kits:  TREVO NXT 3X32+TRAK21 2-PA…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-stryker-neurovascular-z-1905-2024

MLA

"Stryker Neurovascular — Class II recall: Trevo NXT ProVue 3 x 32, US, Catalog: 90312    Kits:  TREVO NXT 3X32+TRAK21 2-PA…." Argus HQ Research, Digital Empire Holdings LLC, 2024, argushq.ai/events/fda-recall-stryker-neurovascular-z-1905-2024.

Chicago

Argus HQ Research. "Stryker Neurovascular — Class II recall: Trevo NXT ProVue 3 x 32, US, Catalog: 90312    Kits:  TREVO NXT 3X32+TRAK21 2-PA…." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-stryker-neurovascular-z-1905-2024.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_stryker_neurovascular_z_1905_2024_2024,
  title = {Stryker Neurovascular — Class II recall: Trevo NXT ProVue 3 x 32, US, Catalog: 90312    Kits:  TREVO NXT 3X32+TRAK21 2-PA…},
  author = {{Argus HQ Research}},
  year = {2024},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-stryker-neurovascular-z-1905-2024},
  note = {Accessed: July 23, 2026}
}

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