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Axela Sheath

Edwards Lifesciences LLC · Model 9630ES14A · UDI-DI 00690103200782

NPU NPT Prescription

510(k) clearances

1,972

Adverse events (417 deaths)

Recalls

Facilities

Description

Axela Sheath (US)

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.