company
Abiomed, Inc.
Jurisdiction: US
FDA Warning Letter timeline
V1 scope: FDA Warning Letters only. Additional public-record sources (SEC, CPSC, federal contracts) are on the V2 roadmap and are not surfaced here today.
- fda_recall · device_recall2026-07-01Abiomed, Inc. — Class I recall: Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14…
- fda_recall · device_recall2026-07-01Abiomed, Inc. — Class I recall: Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14…
- fda_recall · device_recall2026-07-01Abiomed, Inc. — Class I recall: Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Pro…
- fda_recall · device_recall2026-07-01Abiomed, Inc. — Class I recall: Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Pro…
- fda_recall · device_recall2026-06-24Abiomed, Inc. — Class I recall: Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 004…
- fda_recall · device_recall2026-06-24Abiomed, Inc. — Class I recall: Automated Impella Controller (AIC), for use with left heart support blood pump.…
- fda_recall · device_recall2026-06-03Abiomed, Inc. — Class I recall: Automated Impella Controller (AIC) with the below product descriptions and corre…
- fda_recall · device_recall2026-06-03Abiomed, Inc. — Class I recall: Automated Impella Controller (AIC); Product Code: 0042-0000-US;
Frequently asked questions
- How many FDA warning letters has Abiomed, Inc. received?
- Argus HQ has not recorded an FDA warning letter for Abiomed, Inc. in our current dataset.
- What FDA recalls has Abiomed, Inc. issued?
- Argus HQ has recorded 8 FDA recalls tied to Abiomed, Inc..
- Is Abiomed, Inc. FDA compliant?
- Argus HQ is not a compliance rating service. As of this page's last update, our dataset shows 0 warning letters, 8 recalls, and 0 approval records for Abiomed, Inc.. Review the linked FDA source records directly before drawing a compliance conclusion.
Informational only. FDA Warning Letters are public records (17 USC §105). Summaries are AI-assisted and may contain errors; always verify against the original FDA letter before acting. Not legal, financial, or regulatory advice.