FDA action counts (Argus HQ database)
| Total tracked FDA actions | 8 |
|---|---|
| Recalls | 8 |
| Warning letters | 0 |
| Form 483 inspection citations | 0 |
| Most recent tracked action | July 1, 2026 |
| Most severe rating on file | critical |
Recall severity breakdown
Computed from all 8 tracked recalls. FDA classifies each recall Class I (most serious), II, or III on the underlying record; Argus HQ maps that to critical/high/medium/low severity buckets.
| critical | 8 (100.0%) |
|---|
Recall velocity by month
Months with at least one tracked recall for Abiomed, Inc., oldest to most recent. Gaps indicate months with zero tracked recalls, not missing data.
| Month | Recalls |
|---|---|
| 2026-06 | 4 |
| 2026-07 | 4 |
Recurring recall-reason patterns
Argus HQ keyword-matched the free-text “reason for recall” field on each tracked record into categories below. FDA does not publish a structured reason code for device recalls, so this is Argus HQ’s own pattern analysis, not an official FDA classification — records that don’t match a listed keyword fall into “Other.”
| Other / not pattern-matched | 6 recalls |
|---|---|
| Software | 1 recall |
| Battery | 1 recall |
Full recall history (8)
Most recent first. Every row links to its Argus HQ record and FDA.gov source.
Coverage
No independent news coverage was found for Abiomed, Inc.’s FDA recall history at the time this page was published — its enforcement record is small enough that it hasn’t drawn trade-press attention. This page is the most complete public record available.
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Related enforcement actions
Full FDA history for Abiomed, Inc.- Abiomed, Inc. — Class I recall: Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14… →
- Abiomed, Inc. — Class I recall: Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14… →
- Abiomed, Inc. — Class I recall: Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Pro… →
- Abiomed, Inc. — Class I recall: Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Pro… →
- Abiomed, Inc. — Class I recall: Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 004… →
- Abiomed, Inc. — Class I recall: Automated Impella Controller (AIC), for use with left heart support blood pump.… →
- Abiomed, Inc. — Class I recall: Automated Impella Controller (AIC) with the below product descriptions and corre… →
- Abiomed, Inc. — Class I recall: Automated Impella Controller (AIC); Product Code: 0042-0000-US; →
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Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Verified from FDA.gov · Last updated: Jul 1, 2026Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). Abiomed, Inc.: FDA Enforcement History. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/enforcement/abiomed-inc
"Abiomed, Inc.: FDA Enforcement History." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/enforcement/abiomed-inc.
Argus HQ Research. "Abiomed, Inc.: FDA Enforcement History." Digital Empire Holdings LLC. Accessed July 24, 2026. https://argushq.ai/enforcement/abiomed-inc.
@misc{argushq_argushq_ai_enforcement_abiomed_inc_2026,
title = {Abiomed, Inc.: FDA Enforcement History},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/enforcement/abiomed-inc},
note = {Accessed: July 24, 2026}
}