Has Medtronic Perfusion Systems had other FDA enforcement actions?

Yes. Argus HQ has recorded 46 total FDA actions tied to Medtronic Perfusion Systems: 0 warning letters, 46 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 2025-11-26; 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 Perfusion Systems — Class II recall: MC3 VitalFlow Console, REF 58100; Blood pump of ecmo

Name: FDA Recall Record — Medtronic Perfusion Systems
Creator: Argus HQ
Published: 2025-11-26
License: https://argushq.ai/methodology

Event date: 2025-11-26 00:00:00Z
Observed: 2026-07-16 23:20:07Z
Source ID: Z-0509-2026
Payload hash: 613827cb8fb87d4a3921b207…

Summary

As of August 6, 2025, Medtronic has received eleven reports of VitalFlow Consoles displaying an E70 error code during normal operation. When this occurs, the touch screen may become temporarily unresponsive and go blank for up to two minutes before recovering to full functionality. Importantly, the… 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 46 total FDA actions tied to Medtronic Perfusion Systems: 0 warning letters, 46 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 2025-11-26; 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 (2025). Medtronic Perfusion Systems — Class II recall: MC3 VitalFlow Console, REF 58100; Blood pump of ecmo. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-medtronic-perfusion-systems-z-0509-2026

MLA

"Medtronic Perfusion Systems — Class II recall: MC3 VitalFlow Console, REF 58100; Blood pump of ecmo." Argus HQ Research, Digital Empire Holdings LLC, 2025, argushq.ai/events/fda-recall-medtronic-perfusion-systems-z-0509-2026.

Chicago

Argus HQ Research. "Medtronic Perfusion Systems — Class II recall: MC3 VitalFlow Console, REF 58100; Blood pump of ecmo." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-medtronic-perfusion-systems-z-0509-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_medtronic_perfusion_systems_z_0509_2026_2025,
  title = {Medtronic Perfusion Systems — Class II recall: MC3 VitalFlow Console, REF 58100; Blood pump of ecmo},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-medtronic-perfusion-systems-z-0509-2026},
  note = {Accessed: July 23, 2026}
}

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