Has Medtronic Perfusion Systems had other FDA enforcement actions?

Yes. Argus HQ has recorded 54 total FDA actions tied to Medtronic Perfusion Systems: 0 warning letters, 54 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 2026-08-05; Argus observed and indexed it on 2026-08-12.

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 Perfusion Systems — Class II recall: EOPA 3D Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary byp…

Name: FDA Recall Record — Medtronic Perfusion Systems
Creator: Argus HQ
Published: 2026-08-05
License: https://argushq.ai/methodology

Event date: 2026-08-05 00:00:00Z
Observed: 2026-08-12 04:20:22Z
Source ID: Z-2810-2026
Payload hash: 126e0cdbf429ddeeb75606d3…

Summary

Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforation, hypotension, ischemia, and organ dysfunction. Status: Ongoing.

Entities

Medtronic Perfusion Systems

View source record ↗

Frequently asked questions

Has Medtronic Perfusion Systems had other FDA enforcement actions?: Yes. Argus HQ has recorded 54 total FDA actions tied to Medtronic Perfusion Systems: 0 warning letters, 54 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 2026-08-05; Argus observed and indexed it on 2026-08-12.
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 Perfusion Systems — Class II recall: EOPA 3D Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary byp…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-medtronic-perfusion-systems-z-2810-2026

MLA

"Medtronic Perfusion Systems — Class II recall: EOPA 3D Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary byp…." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-medtronic-perfusion-systems-z-2810-2026.

Chicago

Argus HQ Research. "Medtronic Perfusion Systems — Class II recall: EOPA 3D Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary byp…." Digital Empire Holdings LLC. Accessed August 13, 2026. https://argushq.ai/events/fda-recall-medtronic-perfusion-systems-z-2810-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_medtronic_perfusion_systems_z_2810_2026_2026,
  title = {Medtronic Perfusion Systems — Class II recall: EOPA 3D Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary byp…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-medtronic-perfusion-systems-z-2810-2026},
  note = {Accessed: August 13, 2026}
}

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