medical Class II Updated 2025-01-08

Angiodynamics, Inc. recalls AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Produ

Recalled Product

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


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Product Number: EXM-2001-1100, Model Number: EXM001. UDI-DI: 07290017590110, Serial Number: EXM XXX.
View official government recall

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