FDA applicant

Medtronic Cardiac Surgery

Minneapolis2 decisions1981–20240 recalls

FDA records 2 decisions for Medtronic Cardiac Surgery (Minneapolis) from 1981 to 2024: 1 510(k) clearance and 1 original PMA approval. Most are in product codes LWQ (Heart-Valve, Mechanical) and DTN (Reservoir, Blood, Cardiopulmonary Bypass). Its devices cite 1 predicate, 0 of them its own earlier devices. 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 Medtronic Cardiac Surgery’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2007high 1 (2024) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Medtronic Cardiac Surgery

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?