Has Medtronic Heart Valves Division had other FDA enforcement actions?

This is the only FDA action Argus HQ has on file for Medtronic Heart Valves Division as of 2026-07-14. Argus ingests new FDA enforcement records daily.

What kind of FDA record is this?

This is an Argus HQ record of a FDA Recall, tagged critical severity by Argus HQ. FDA published the underlying record on 2026-07-08; Argus observed and indexed it on 2026-07-14.

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 · critical

Medtronic Heart Valves Division — Class I recall: Medtronic Harmony Delivery Catheter System

Name: FDA Recall Record — Medtronic Heart Valves Division
Creator: Argus HQ
Published: 2026-07-08
License: https://argushq.ai/methodology

Event date: 2026-07-08 00:00:00Z
Observed: 2026-07-14 04:20:25Z
Source ID: Z-2624-2026
Payload hash: fff0c870736caee15b3b362c…

Summary

Devices containing inner shaft assemblies from specific manufacturing lots may have an increased potential for distal tip detachment from the delivery system under certain procedural or anatomical conditions due to a manufacturing issue. Status: Ongoing.

Entities

Medtronic Heart Valves Division

View source record ↗

Frequently asked questions

Has Medtronic Heart Valves Division had other FDA enforcement actions?: This is the only FDA action Argus HQ has on file for Medtronic Heart Valves Division as of 2026-07-14. Argus ingests new FDA enforcement records daily.
What kind of FDA record is this?: This is an Argus HQ record of a FDA Recall, tagged critical severity by Argus HQ. FDA published the underlying record on 2026-07-08; Argus observed and indexed it on 2026-07-14.
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 Heart Valves Division — Class I recall: Medtronic Harmony Delivery Catheter System. Digital Empire LLC. Retrieved from https://argushq.ai/events/fda-recall-medtronic-heart-valves-division-z-2624-2026

MLA

"Medtronic Heart Valves Division — Class I recall: Medtronic Harmony Delivery Catheter System." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/events/fda-recall-medtronic-heart-valves-division-z-2624-2026.

Chicago

Argus HQ Research. "Medtronic Heart Valves Division — Class I recall: Medtronic Harmony Delivery Catheter System." Digital Empire LLC. Accessed July 14, 2026. https://argushq.ai/events/fda-recall-medtronic-heart-valves-division-z-2624-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_medtronic_heart_valves_division_z_2624_2026_2026,
  title = {Medtronic Heart Valves Division — Class I recall: Medtronic Harmony Delivery Catheter System},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/events/fda-recall-medtronic-heart-valves-division-z-2624-2026},
  note = {Accessed: July 14, 2026}
}

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