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 2026-07-22; Argus observed and indexed it on 2026-07-28.

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, Pump Set Code 0048-0014; containing Introducer Product C…

Name: FDA Recall Record — Abiomed, Inc.
Creator: Argus HQ
Published: 2026-07-22
License: https://argushq.ai/methodology

Event date: 2026-07-22 00:00:00Z
Observed: 2026-07-28 04:20:58Z
Source ID: Z-2689-2026
Payload hash: 75bd4a9719cb85cf2fd30c6f…

Summary

A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set. 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 2026-07-22; Argus observed and indexed it on 2026-07-28.
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, Pump Set Code 0048-0014; containing Introducer Product C…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-abiomed-inc-z-2689-2026

MLA

"Abiomed, Inc. — Class I recall: ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product C…." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-abiomed-inc-z-2689-2026.

Chicago

Argus HQ Research. "Abiomed, Inc. — Class I recall: ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product C…." Digital Empire Holdings LLC. Accessed July 28, 2026. https://argushq.ai/events/fda-recall-abiomed-inc-z-2689-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_abiomed_inc_z_2689_2026_2026,
  title = {Abiomed, Inc. — Class I recall: ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product C…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-abiomed-inc-z-2689-2026},
  note = {Accessed: July 28, 2026}
}

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