What is the most recent FDA action on file for Abiomed, Inc.?

July 22, 2026. Argus HQ ingests new FDA enforcement records daily.

Has Abiomed, Inc. had product recalls?

Yes, 21 recalls on file. See the full history below for each one.

Is this FDA enforcement data for Abiomed, Inc. official?

Every record links directly to its primary FDA.gov source. Argus HQ aggregates and structures public FDA data; the verbatim FDA record is always the source of truth.

How many FDA actions has Abiomed, Inc. had?

Argus HQ has recorded 8 FDA events for Abiomed, Inc.: 0 warning letters, 8 recalls, 0 approvals, and 0 Form 483 inspection observations. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

Abiomed, Inc. — FDA Enforcement History

FDA action counts

Total FDA actions	21
Warning letters	0
Recalls	21
Approval records	0
Form 483 inspection citations	0
Most recent action	July 22, 2026

The short version: Argus HQ has recorded 8 FDA events for Abiomed, Inc.: 0 warning letters, 8 recalls, 0 approvals, and 0 inspection 483 observations. These events span from 2026-06-03 to 2026-07-01. The most severe rating Argus HQ has assigned across this history is "critical". 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.

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. Abiomed, Inc. has 8 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.

Enforcement history

On 2026-06-03, Argus HQ recorded a FDA recall for Abiomed, Inc., rated "critical" severity in Argus HQ's classification: Abiomed, Inc. — Class I recall: Automated Impella Controller (AIC) with the below product descriptions and corre… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-06-03, Argus HQ recorded a FDA recall for Abiomed, Inc., rated "critical" severity in Argus HQ's classification: Abiomed, Inc. — Class I recall: Automated Impella Controller (AIC); Product Code: 0042-0000-US; An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-06-24, Argus HQ recorded a FDA recall for Abiomed, Inc., rated "critical" severity in Argus HQ's classification: Abiomed, Inc. — Class I recall: Automated Impella Controller (AIC), for use with left heart support blood pump.… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-06-24, Argus HQ recorded a FDA recall for Abiomed, Inc., rated "critical" severity in Argus HQ's classification: Abiomed, Inc. — Class I recall: Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 004… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-07-01, Argus HQ recorded a FDA recall for Abiomed, Inc., rated "critical" severity in Argus HQ's classification: Abiomed, Inc. — Class I recall: Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-07-01, Argus HQ recorded a FDA recall for Abiomed, Inc., rated "critical" severity in Argus HQ's classification: Abiomed, Inc. — Class I recall: Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Pro… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-07-01, Argus HQ recorded a FDA recall for Abiomed, Inc., rated "critical" severity in Argus HQ's classification: Abiomed, Inc. — Class I recall: Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Pro… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-07-01, Argus HQ recorded a FDA recall for Abiomed, Inc., rated "critical" severity in Argus HQ's classification: Abiomed, Inc. — Class I recall: Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. In total, Abiomed, Inc. has 8 FDA events on file with Argus HQ across the sources Argus HQ currently tracks (FDA Warning Letters, recalls, drug/biologic approvals, and Form 483 inspection observations).

Frequently asked questions

What is the most recent FDA action on file for Abiomed, Inc.?: July 22, 2026. Argus HQ ingests new FDA enforcement records daily.
Has Abiomed, Inc. had product recalls?: Yes, 21 recalls on file. See the full history below for each one.
Is this FDA enforcement data for Abiomed, Inc. official?: Every record links directly to its primary FDA.gov source. Argus HQ aggregates and structures public FDA data; the verbatim FDA record is always the source of truth.
How many FDA actions has Abiomed, Inc. had?: Argus HQ has recorded 8 FDA events for Abiomed, Inc.: 0 warning letters, 8 recalls, 0 approvals, and 0 Form 483 inspection observations. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

Every FDA action tied to this company, the week it happens.

Free weekly briefing. Real-time alerts on paid plans.

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: Jul 22, 2026

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). Abiomed, Inc. — FDA Enforcement History. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/company/abiomed-inc

MLA

"Abiomed, Inc. — FDA Enforcement History." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/company/abiomed-inc.

Chicago

Argus HQ Research. "Abiomed, Inc. — FDA Enforcement History." Digital Empire Holdings LLC. Accessed August 27, 2026. https://argushq.ai/company/abiomed-inc.

BibTeX

@misc{argushq_argushq_ai_company_abiomed_inc_2026,
  title = {Abiomed, Inc. — FDA Enforcement History},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/company/abiomed-inc},
  note = {Accessed: August 27, 2026}
}

Source: FDA.gov (aggregated across Warning Letters, Recalls, Approvals, Form 483s) ↗