FDA action counts
| Total FDA actions | 4 |
|---|---|
| Warning letters | 0 |
| Recalls | 4 |
| Approval records | 0 |
| Form 483 inspection citations | 0 |
| Most recent action | January 1, 2025 |
Risk pattern analysis
Argus HQ analysis — not an FDA finding
This section is Argus HQ analysis, not an FDA finding. Abbott Vascular Inc has 4 separate FDA recalls on file, more than a single isolated recall event. A pattern across multiple FDA touchpoints does not by itself establish that any specific product currently poses a risk; it reflects only the frequency of FDA engagement with this company as recorded in Argus HQ's database. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ does not independently verify FDA's underlying findings; this page summarizes what FDA has published and links back to the original FDA source for each event. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.
Enforcement history
On 2025-01-01, Argus HQ recorded an FDA recall for Abbott Vascular Inc, rated "high" severity in Argus HQ's classification: Abbott Vascular Inc — Class II recall: 20/30 INDEFLATOR, REF: 1000184, for use during cardiovascular procedures in conj…. On 2025-01-01, Argus HQ recorded an FDA recall for Abbott Vascular Inc, rated "high" severity in Argus HQ's classification: Abbott Vascular Inc — Class II recall: 20/30 Priority Pack Accessory Kit w/Copilot, REF: 1003327, used for cardiovascul…. On 2025-01-01, Argus HQ recorded an FDA recall for Abbott Vascular Inc, rated "high" severity in Argus HQ's classification: Abbott Vascular Inc — Class II recall: 20/30 Priority Pack Accessory Kit/.096 RHV, REF: 1000186, or use during vascular…. On 2025-01-01, Argus HQ recorded an FDA recall for Abbott Vascular Inc, rated "high" severity in Argus HQ's classification: Abbott Vascular Inc — Class II recall: 20/30 Priority Pack Kit/.115 RHV, REF: 1000186-115, used for cardiovascular proc…. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed.
Frequently asked questions
- Does Argus HQ track new FDA actions for Abbott Vascular Inc automatically?
- Yes. Argus HQ ingests FDA sources daily, including FDA warning letters, recalls, drug and biologic approvals, and Form 483 inspection observations. When a new FDA action linked to Abbott Vascular Inc is observed, this page's event count and history update automatically.
- How many FDA actions does Argus HQ track for Abbott Vascular Inc?
- 4 total: 0 warning letters, 4 recalls, 0 approval records, and 0 Form 483 inspection citations.
- What is the most recent FDA action on file for Abbott Vascular Inc?
- January 1, 2025. Argus HQ ingests new FDA enforcement records daily.
- Has Abbott Vascular Inc had product recalls?
- Yes, 4 recalls on file. See the full history below for each one.
Every FDA action tied to this company, the week it happens.
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Related enforcement actions
- Abbott Vascular Inc — Class II recall: 20/30 Priority Pack Kit/.115 RHV, REF: 1000186-115, used for cardiovascular proc… →
- Abbott Vascular Inc — Class II recall: 20/30 Priority Pack Accessory Kit/.096 RHV, REF: 1000186, or use during vascular… →
- Abbott Vascular Inc — Class II recall: 20/30 Priority Pack Accessory Kit w/Copilot, REF: 1003327, used for cardiovascul… →
- Abbott Vascular Inc — Class II recall: 20/30 INDEFLATOR, REF: 1000184, for use during cardiovascular procedures in conj… →
Compare with
Two different companies merged onto this page by mistake? Or a name variant missing? Tell us — corrections@argushq.ai
Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Verified from FDA.gov · Last updated: Jan 1, 2025Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2025). FDA Enforcement History: Abbott Vascular Inc. Digital Empire LLC. Retrieved from https://argushq.ai/company/abbott-vascular-inc
"FDA Enforcement History: Abbott Vascular Inc." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/company/abbott-vascular-inc.
Argus HQ Research. "FDA Enforcement History: Abbott Vascular Inc." Digital Empire LLC. Accessed July 17, 2026. https://argushq.ai/company/abbott-vascular-inc.
@misc{argushq_argushq_ai_company_abbott_vascular_inc_2025,
title = {FDA Enforcement History: Abbott Vascular Inc},
author = {{Argus HQ Research}},
year = {2025},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/company/abbott-vascular-inc},
note = {Accessed: July 17, 2026}
}Source: FDA.gov (aggregated across Warning Letters, Recalls, Approvals, Form 483s) ↗