FDA action counts (Argus HQ database)
| Total tracked FDA actions | 21 |
|---|---|
| Recalls | 21 |
| Warning letters | 0 |
| Form 483 inspection citations | 0 |
| Most recent tracked action | July 22, 2026 |
| Most severe rating on file | critical |
Recall severity breakdown
Computed from all 21 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 | 21 (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 | 17 |
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 | 19 recalls |
|---|---|
| Software | 1 recall |
| Battery | 1 recall |
Full recall history (21)
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 RP Flex with SmartAssist Set, Pump Set Code 1000323, containing… →
- Abiomed, Inc. — Class I recall: ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, contain… →
- Abiomed, Inc. — Class I recall: ABIOMED Introducer Kit 23 Fr, 11 cm, Pump Set Code 1000441, containing Kit, 23Fr… →
- Abiomed, Inc. — Class I recall: ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product C… →
- Abiomed, Inc. — Class I recall: ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Intro… →
- Abiomed, Inc. — Class I recall: ABIOMED Impella 5.5 SmartAssist S2 Set, JP, Pump Set Codes 1000459, 1000460; con… →
- Abiomed, Inc. — Class I recall: ABIOMED Impella CP Introducer Kit 14 Fr, 25 cm, Pump Set Code 0052-0039, contain… →
- Abiomed, Inc. — Class I recall: ABIOMED Impella 5.5 Smart Assist Set, JP, Pump Set Codes 1000211, 1000212; conta… →
- Abiomed, Inc. — Class I recall: ABIOMED Intro Kit, 14Fr x 13 and 25 cm, PKGD, JP, Pump Set Code 0052-0023-JP; co… →
- Abiomed, Inc. — Class I recall: ABIOMED Impella CP Smart Assist Set, JP, Pump Set Code 0048-0024-JP; containing… →
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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 22, 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 September 7, 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: September 7, 2026}
}