Abiomed Inc.
Danvers, MA
Works in Cardiovascular
Abiomed Inc. is a clinical trial sponsor based in Danvers, MA. It has 12 active clinical trials with 4,028 planned participants, in Cardiovascular. Since 2021 it has completed 7 trials and stopped 1 early. Its FDA record on file shows 4 recalls.
Trial track record · since 2021
FDA record
Recent FDA actions
Pipeline · 12 active trials
| Stage | Trial | Status |
|---|---|---|
Questions about Abiomed Inc
No warning letter naming Abiomed Inc is on file. FDA has published 4 recalls naming it.
Yes. FDA's enforcement reports list 4 recalls by Abiomed Inc; the latest, reported on 2026-09-30, is a Class II recall.
Abiomed Inc is lead sponsor of 12 active clinical trials on ClinicalTrials.gov, with 4,028 planned participants, in Cardiovascular. Since 2021 it has completed 7 trials and stopped 1 early.
Abiomed Inc is based in Danvers, MA. The address is the one on its FDA records or ClinicalTrials.gov registrations, which name the establishment or the registrant, not always the group's head office.
From public sources only: ClinicalTrials.gov for trials, FDA's Data Dashboard, warning-letter listing and enforcement reports for the FDA record, and SEC filings for financials. Approve Suite is not affiliated with Abiomed Inc; every record links to the source, and nothing here is advice.
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Trial counts are as the sponsor reported them to ClinicalTrials.gov, for trials changed since 2021; latest update 2026-10-13.
The FDA record counts inspection classifications, warning letters and recalls FDA has published that name this company. Compare it with the industry in the free CDMO FDA inspection lookup.
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