Has Abiomed, Inc. had other FDA enforcement actions?

Yes. Argus HQ has recorded 25 total FDA actions tied to Abiomed, Inc.: 0 warning letters, 25 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 2026-09-30; Argus observed and indexed it on 2026-10-06.

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

Abiomed, Inc. — Class II recall: Automated Impella Controller (AIC) with the below product descriptions and corre…

Name: FDA Recall Record — Abiomed, Inc.
Creator: Argus HQ
Published: 2026-09-30
License: https://argushq.ai/methodology

Event date: 2026-09-30 00:00:00Z
Observed: 2026-10-06 04:20:24Z
Source ID: Z-3251-2026
Payload hash: d5f5e8eaa6fd4159af8ec344…

Summary

Retrospective report of issues remedied in 2019 with firmware and software patches: 1. Defects in optical bench (OPB) firmware V2.19, which affected the accuracy and stability of the pressure signal the AIC system performance depends on. 2. Software defects leading to unreliable or missing placem… Status: Ongoing.

Entities

Abiomed, Inc.

View source record ↗

Frequently asked questions

Has Abiomed, Inc. had other FDA enforcement actions?: Yes. Argus HQ has recorded 25 total FDA actions tied to Abiomed, Inc.: 0 warning letters, 25 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 2026-09-30; Argus observed and indexed it on 2026-10-06.
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 (2026). Abiomed, Inc. — Class II recall: Automated Impella Controller (AIC) with the below product descriptions and corre…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-abiomed-inc-z-3251-2026

MLA

"Abiomed, Inc. — Class II recall: Automated Impella Controller (AIC) with the below product descriptions and corre…." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-abiomed-inc-z-3251-2026.

Chicago

Argus HQ Research. "Abiomed, Inc. — Class II recall: Automated Impella Controller (AIC) with the below product descriptions and corre…." Digital Empire Holdings LLC. Accessed October 6, 2026. https://argushq.ai/events/fda-recall-abiomed-inc-z-3251-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_abiomed_inc_z_3251_2026_2026,
  title = {Abiomed, Inc. — Class II recall: Automated Impella Controller (AIC) with the below product descriptions and corre…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-abiomed-inc-z-3251-2026},
  note = {Accessed: October 6, 2026}
}

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