Has Medtronic, Inc. had other FDA enforcement actions?

Yes. Argus HQ has recorded 40 total FDA actions tied to Medtronic, Inc.: 0 warning letters, 40 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 2023-11-29; 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 Inc — Class II recall: Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM01300…

Name: FDA Recall Record — Medtronic, Inc.
Creator: Argus HQ
Published: 2023-11-29
License: https://argushq.ai/methodology

Event date: 2023-11-29 00:00:00Z
Observed: 2026-07-16 23:20:08Z
Source ID: Z-0322-2024
Payload hash: d8f5debab30118083c3fa9b1…

Summary

The Mo.Ma Ultra device manifold is labelled with 2 stickers, an inferior and superior sticker, one on each side of the manifold. These stickers label the common carotid artery (CCA) proximal balloon and external carotid artery (ECA) distal balloon inflation and deflation ports. Both sides of the com… Status: Ongoing.

Entities

Medtronic, Inc.

View source record ↗

Frequently asked questions

Has Medtronic, Inc. had other FDA enforcement actions?: Yes. Argus HQ has recorded 40 total FDA actions tied to Medtronic, Inc.: 0 warning letters, 40 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 2023-11-29; 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 (2023). Medtronic Inc — Class II recall: Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM01300…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-medtronic-inc-z-0322-2024

MLA

"Medtronic Inc — Class II recall: Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM01300…." Argus HQ Research, Digital Empire Holdings LLC, 2023, argushq.ai/events/fda-recall-medtronic-inc-z-0322-2024.

Chicago

Argus HQ Research. "Medtronic Inc — Class II recall: Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM01300…." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-medtronic-inc-z-0322-2024.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_medtronic_inc_z_0322_2024_2023,
  title = {Medtronic Inc — Class II recall: Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM01300…},
  author = {{Argus HQ Research}},
  year = {2023},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-medtronic-inc-z-0322-2024},
  note = {Accessed: July 23, 2026}
}

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