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fda_recall · device_recall · high

Medtronic Perfusion Systems — Class II recall: Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94…

Event date
2026-05-27 00:00:00Z
Observed
2026-07-09 22:52:26Z
Source ID
Z-2219-2026
Payload hash
0c7f2256ad84a38e696c9271

Summary

Certain lots of product have the potential for a sterile barrier breach. Status: Ongoing.

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 2026-05-27; Argus observed and indexed it on 2026-07-09.
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: Medtronic DLP Retrograde Cannula   Manual-Inflate   Silicone Body 13FR, Model 94…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-medtronic-perfusion-systems-z-2219-2026
MLA
"Medtronic Perfusion Systems — Class II recall: Medtronic DLP Retrograde Cannula   Manual-Inflate   Silicone Body 13FR, Model 94…." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-medtronic-perfusion-systems-z-2219-2026.
Chicago
Argus HQ Research. "Medtronic Perfusion Systems — Class II recall: Medtronic DLP Retrograde Cannula   Manual-Inflate   Silicone Body 13FR, Model 94…." Digital Empire Holdings LLC. Accessed August 27, 2026. https://argushq.ai/events/fda-recall-medtronic-perfusion-systems-z-2219-2026.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_medtronic_perfusion_systems_z_2219_2026_2026,
  title = {Medtronic Perfusion Systems — Class II recall: Medtronic DLP Retrograde Cannula   Manual-Inflate   Silicone Body 13FR, Model 94…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-medtronic-perfusion-systems-z-2219-2026},
  note = {Accessed: August 27, 2026}
}

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