Has Abbott had other FDA enforcement actions?

Yes. Argus HQ has recorded 11 total FDA actions tied to Abbott: 0 warning letters, 11 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 critical severity by Argus HQ. FDA published the underlying record on 2023-07-19; 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 · critical

Abbott — Class I recall: Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percut…

Name: FDA Recall Record — Abbott
Creator: Argus HQ
Published: 2023-07-19
License: https://argushq.ai/methodology

Event date: 2023-07-19 00:00:00Z
Observed: 2026-07-16 23:20:09Z
Source ID: Z-2110-2023
Payload hash: 76bfec8fa100a1820f4e9882…

Summary

There is an overall reported incidence rate of 0.77% related to observed or potential air embolism during procedures in which the ASDS product was used. Status: Ongoing.

Entities

Abbott

View source record ↗

Frequently asked questions

Has Abbott had other FDA enforcement actions?: Yes. Argus HQ has recorded 11 total FDA actions tied to Abbott: 0 warning letters, 11 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 critical severity by Argus HQ. FDA published the underlying record on 2023-07-19; 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). Abbott — Class I recall: Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percut…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-abbott-z-2110-2023

MLA

"Abbott — Class I recall: Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percut…." Argus HQ Research, Digital Empire Holdings LLC, 2023, argushq.ai/events/fda-recall-abbott-z-2110-2023.

Chicago

Argus HQ Research. "Abbott — Class I recall: Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percut…." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-abbott-z-2110-2023.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_abbott_z_2110_2023_2023,
  title = {Abbott — Class I recall: Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percut…},
  author = {{Argus HQ Research}},
  year = {2023},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-abbott-z-2110-2023},
  note = {Accessed: July 23, 2026}
}

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