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fda_recall · device_recall · high

Medtronic MiniMed, Inc. — Class II recall: Guardian 4 Glucose Sensor, REF: MMT-7040A, MMT-7040C1, MMT-7040C2, MMT-7040C3, M…

Event date
2024-02-14 00:00:00Z
Observed
2026-07-16 23:20:08Z
Source ID
Z-1005-2024
Payload hash
ae38c3105b8b6491d60695d7

Summary

Some sensors may have a glucose oxidase (GOX) layer thickness outside of specification (5.5 to 9.2 ¿m). A non-conforming GOX layer thickness could impact sensor function (sensor glucose value) or loss of sensor function due to the sensor layer being too thin. The potential impact resulting from this… Status: Ongoing.

Frequently asked questions

Has Medtronic MiniMed, Inc. had other FDA enforcement actions?
Yes. Argus HQ has recorded 38 total FDA actions tied to Medtronic MiniMed, Inc.: 0 warning letters, 38 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 2024-02-14; 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 (2024). Medtronic MiniMed, Inc. — Class II recall: Guardian 4 Glucose Sensor, REF: MMT-7040A, MMT-7040C1, MMT-7040C2, MMT-7040C3, M…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-medtronic-minimed-inc-z-1005-2024
MLA
"Medtronic MiniMed, Inc. — Class II recall: Guardian 4 Glucose Sensor, REF: MMT-7040A, MMT-7040C1, MMT-7040C2, MMT-7040C3, M…." Argus HQ Research, Digital Empire Holdings LLC, 2024, argushq.ai/events/fda-recall-medtronic-minimed-inc-z-1005-2024.
Chicago
Argus HQ Research. "Medtronic MiniMed, Inc. — Class II recall: Guardian 4 Glucose Sensor, REF: MMT-7040A, MMT-7040C1, MMT-7040C2, MMT-7040C3, M…." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-medtronic-minimed-inc-z-1005-2024.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_medtronic_minimed_inc_z_1005_2024_2024,
  title = {Medtronic MiniMed, Inc. — Class II recall: Guardian 4 Glucose Sensor, REF: MMT-7040A, MMT-7040C1, MMT-7040C2, MMT-7040C3, M…},
  author = {{Argus HQ Research}},
  year = {2024},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-medtronic-minimed-inc-z-1005-2024},
  note = {Accessed: July 23, 2026}
}

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