Angiodynamics, Inc. recalls AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100

Recall date

November 25, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0770-2025

FDA classification

Class II

Brand / firm

Angiodynamics, Inc.

Sold / distributed

US Nationwide distribution to the states of AR, AZ, CA, CO, CT, FL, GA, IL, IN, KY, LA, MD, MI, MN, MO, MS, NC, NJ, NM, NY, OH, PA, RI, TN, TX, VA, WA, WI.

Why it was recalled

Potential for procedural delays or interruptions during use of the Auryon Atherectomy System due to the Auryon Atherectomy System not advancing to the Activation (Ready) mode.

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

What was recalled

AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100