FDA applicant

Farapulse, Inc.

Menlo Park1 decision2024–20245 recalls

FDA records 1 decision for Farapulse, Inc. (Menlo Park) in 2024: 1 original PMA approval. All are in product code QZI (Percutaneous Cardiac Ablation Catheter For…). 5 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 Farapulse, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2024high 1 (2024) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

4in 2026

2024high 4 (2026) · low 0 (2024)2026

Class I Class II/III not classified

FIG. 1 — Farapulse, Inc. by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Farapulse, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

What has been recalled?