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 2023-02-08; 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: Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurfac…

Name: FDA Recall Record — Medtronic Perfusion Systems
Creator: Argus HQ
Published: 2023-02-08
License: https://argushq.ai/methodology

Event date: 2023-02-08 00:00:00Z
Observed: 2026-07-16 23:20:09Z
Source ID: Z-1026-2023
Payload hash: c12909c81d755daa02140052…

Summary

An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator either during pre-procedure perfusion set-up or post-procedure when disassembling the perfusion circuit. 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 2023-02-08; 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 Perfusion Systems — Class II recall: Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurfac…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-medtronic-perfusion-systems-z-1026-2023

MLA

"Medtronic Perfusion Systems — Class II recall: Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurfac…." Argus HQ Research, Digital Empire Holdings LLC, 2023, argushq.ai/events/fda-recall-medtronic-perfusion-systems-z-1026-2023.

Chicago

Argus HQ Research. "Medtronic Perfusion Systems — Class II recall: Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurfac…." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-medtronic-perfusion-systems-z-1026-2023.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_medtronic_perfusion_systems_z_1026_2023_2023,
  title = {Medtronic Perfusion Systems — Class II recall: Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurfac…},
  author = {{Argus HQ Research}},
  year = {2023},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-medtronic-perfusion-systems-z-1026-2023},
  note = {Accessed: July 23, 2026}
}

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