Has Medtronic, Inc. had other FDA enforcement actions?

Yes. Argus HQ has recorded 40 total FDA actions tied to Medtronic, Inc.: 0 warning letters, 40 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 2025-07-23; 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, Inc. — Class II recall: Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model…

Name: FDA Recall Record — Medtronic, Inc.
Creator: Argus HQ
Published: 2025-07-23
License: https://argushq.ai/methodology

Event date: 2025-07-23 00:00:00Z
Observed: 2026-07-16 23:20:07Z
Source ID: Z-2128-2025
Payload hash: cd26e5ec64614ba36c80afee…

Summary

A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. The update eliminates the potential display of an erroneous electrical reset (pop-up) message upon interrogation with a SmartSync Device Manager. The erroneous message indicates an electrical reset has o… Status: Ongoing.

Entities

Medtronic, Inc.

View source record ↗

Frequently asked questions

Has Medtronic, Inc. had other FDA enforcement actions?: Yes. Argus HQ has recorded 40 total FDA actions tied to Medtronic, Inc.: 0 warning letters, 40 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 2025-07-23; 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, Inc. — Class II recall: Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-medtronic-inc-z-2128-2025

MLA

"Medtronic, Inc. — Class II recall: Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model…." Argus HQ Research, Digital Empire Holdings LLC, 2025, argushq.ai/events/fda-recall-medtronic-inc-z-2128-2025.

Chicago

Argus HQ Research. "Medtronic, Inc. — Class II recall: Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model…." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-medtronic-inc-z-2128-2025.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_medtronic_inc_z_2128_2025_2025,
  title = {Medtronic, Inc. — Class II recall: Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model…},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-medtronic-inc-z-2128-2025},
  note = {Accessed: July 23, 2026}
}

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