FDA applicant

Abiomed Cardiovascular, Inc.

Danvers1 decision1992–19923 recalls

FDA records 1 decision for Abiomed Cardiovascular, Inc. (Danvers) in 1992: 1 original PMA approval. All are in product code DSQ (Ventricular (Assist) Bypass). 3 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Abiomed Cardiovascular, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Abiomed Cardiovascular, Inc. since 2007.

Recalls per year

2in 2009

2007high 2 (2009) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Abiomed Cardiovascular, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Abiomed”

FDA records each applicant name separately; these may or may not be the same firm.

Abiomed, Inc. 21

Abiomed Cardiovascular, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Abiomed”