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 high severity by Argus HQ. FDA published the underlying record on 2025-04-30; 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

Abbott — Class II recall: Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVL…

Name: FDA Recall Record — Abbott
Creator: Argus HQ
Published: 2025-04-30
License: https://argushq.ai/methodology

Event date: 2025-04-30 00:00:00Z
Observed: 2026-07-16 23:20:09Z
Source ID: Z-1643-2025
Payload hash: b5c50f3593aaf59740d2ef37…

Summary

Device may have a small breach in the proximal end of the shaft under the strain relief of the delivery system. Breach is not visibly detectable and may lead to prolonged procedure, blood loss, or air ingress with potential for air embolism. 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 high severity by Argus HQ. FDA published the underlying record on 2025-04-30; 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). Abbott — Class II recall: Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVL…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-abbott-z-1643-2025

MLA

"Abbott — Class II recall: Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVL…." Argus HQ Research, Digital Empire Holdings LLC, 2025, argushq.ai/events/fda-recall-abbott-z-1643-2025.

Chicago

Argus HQ Research. "Abbott — Class II recall: Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVL…." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-abbott-z-1643-2025.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_abbott_z_1643_2025_2025,
  title = {Abbott — Class II recall: Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVL…},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-abbott-z-1643-2025},
  note = {Accessed: July 23, 2026}
}

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