Has Edwards Lifesciences, LLC had other FDA enforcement actions?

Yes. Argus HQ has recorded 17 total FDA actions tied to Edwards Lifesciences, LLC: 0 warning letters, 17 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 2023-11-15; 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

Edwards Lifesciences, LLC — Class II recall: Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35

Name: FDA Recall Record — Edwards Lifesciences, LLC
Creator: Argus HQ
Published: 2023-11-15
License: https://argushq.ai/methodology

Event date: 2023-11-15 00:00:00Z
Observed: 2026-07-16 23:20:10Z
Source ID: Z-0238-2024
Payload hash: 7775573c4a0b70e2bf1d8eae…

Summary

Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds). Status: Ongoing.

Entities

Edwards Lifesciences, LLC

View source record ↗

Frequently asked questions

Has Edwards Lifesciences, LLC had other FDA enforcement actions?: Yes. Argus HQ has recorded 17 total FDA actions tied to Edwards Lifesciences, LLC: 0 warning letters, 17 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 2023-11-15; 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). Edwards Lifesciences, LLC — Class II recall: Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35. Digital Empire LLC. Retrieved from https://argushq.ai/events/fda-recall-edwards-lifesciences-llc-z-0238-2024

MLA

"Edwards Lifesciences, LLC — Class II recall: Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35." Argus HQ Research, Digital Empire LLC, 2023, argushq.ai/events/fda-recall-edwards-lifesciences-llc-z-0238-2024.

Chicago

Argus HQ Research. "Edwards Lifesciences, LLC — Class II recall: Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35." Digital Empire LLC. Accessed July 17, 2026. https://argushq.ai/events/fda-recall-edwards-lifesciences-llc-z-0238-2024.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_edwards_lifesciences_llc_z_0238_2024_2023,
  title = {Edwards Lifesciences, LLC — Class II recall: Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35},
  author = {{Argus HQ Research}},
  year = {2023},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/events/fda-recall-edwards-lifesciences-llc-z-0238-2024},
  note = {Accessed: July 17, 2026}
}

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