Auryon Laser Atherectomy System Recalled for Activation Failure
Angiodynamics is recalling 138 units of the Auryon atherectomy laser system due to potential failure to advance to activation mode during use. This malfunction could cause procedural delays or interruptions.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II device with no reported illnesses or injuries. The hazard is a functional malfunction causing potential procedural delays rather than direct patient harm.
Plain-English summary
The Auryon Atherectomy Laser System (Model EXM001, Product Number EXM-2001-1100) manufactured by Angiodynamics is subject to a recall affecting 138 units. The systems may fail to advance to their Activation (Ready) mode during use.
When the device does not advance to activation mode, it could result in procedural delays or interruptions during vascular intervention procedures. This malfunction prevents normal operation of the device during patient treatment.
The recalled units were distributed nationwide to healthcare facilities in Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, New York, Ohio, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia, Washington, and Wisconsin. Units can be identified by Model Number EXM001, Product Number EXM-2001-1100, or UDI-DI 07290017590110.
Healthcare providers should contact Angiodynamics for information about the recall, including replacement or repair options for affected systems.
The recalled product
- Product
- AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100
- Manufacturer
- Angiodynamics, Inc.
- Category
- Medical Device
- Affected units
- 138
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Product Number: EXM-2001-1100
- Model Number: EXM001. UDI-DI: 07290017590110
- Serial Number: EXM XXX.
Distribution
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