FDA applicant

Lungpacer Medical USA, Inc.

Exton1 decision2024–20240 recalls

FDA records 1 decision for Lungpacer Medical USA, Inc. (Exton) in 2024: 1 original PMA approval. All are in product code SDL (Transvenous Temporary Phrenic Nerve Stimulator). 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, anesthesiology panel, where it files most

How often FDA has decided Lungpacer Medical USA, 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

No recall linked to its devices since 2024.

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

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Lungpacer Medical USA, Inc.

Which product codes does it file in?

What has FDA decided for it lately?