Has Abiomed, Inc. had other FDA enforcement actions?

Yes. Argus HQ has recorded 21 total FDA actions tied to Abiomed, Inc.: 0 warning letters, 21 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 2026-07-01; Argus observed and indexed it on 2026-07-09.

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

Abiomed, Inc. — Class I recall: Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14…

Name: FDA Recall Record — Abiomed, Inc.
Creator: Argus HQ
Published: 2026-07-01
License: https://argushq.ai/methodology

Event date: 2026-07-01 00:00:00Z
Observed: 2026-07-09 22:51:56Z
Source ID: Z-2602-2026
Payload hash: 69c3e9dd3d2e961c9a96850d…

Summary

Potential for thrombus formation during prolonged use of the introducer. Status: Ongoing.

Entities

Abiomed, Inc.

View source record ↗

Frequently asked questions

Has Abiomed, Inc. had other FDA enforcement actions?: Yes. Argus HQ has recorded 21 total FDA actions tied to Abiomed, Inc.: 0 warning letters, 21 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 2026-07-01; Argus observed and indexed it on 2026-07-09.
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 I recall: Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-abiomed-inc-z-2602-2026

MLA

"Abiomed, Inc. — Class I recall: Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14…." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-abiomed-inc-z-2602-2026.

Chicago

Argus HQ Research. "Abiomed, Inc. — Class I recall: Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14…." Digital Empire Holdings LLC. Accessed August 27, 2026. https://argushq.ai/events/fda-recall-abiomed-inc-z-2602-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_abiomed_inc_z_2602_2026_2026,
  title = {Abiomed, Inc. — Class I recall: Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-abiomed-inc-z-2602-2026},
  note = {Accessed: August 27, 2026}
}

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