Medical device recalls Moderate risk

Atrium Medical Corporation recalls iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616

Recall date
September 9, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0024-2025
FDA classification
Class II
Brand / firm
Atrium Medical Corporation
Sold / distributed
US Nationwide distribution in the states of FL, MA, MI, OH, WA.

Why it was recalled

There is an error in the Unique Device Identifier (UDI) printed on the product's distribution label.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616

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