FDA applicant

Worldheart, Inc.

Oakland1 decision1998–19980 recalls

FDA records 1 decision for Worldheart, Inc. (Oakland) in 1998: 1 original PMA approval. All are in product code DSQ (Ventricular (Assist) Bypass). No recall is 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 Worldheart, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Worldheart, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Worldheart, Inc.

Which product codes does it file in?

What has FDA decided for it lately?