AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001.… recallZ-0770-2025 · Angiodynamics, Inc. · initiated Nov 25, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Angiodynamics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Under Investigation by firm
What the company is doing
AngioDynamics notified consignees on about 11/25/2024 via URGENT VOLUNTARY MEDICAL DEVICE CORRECTION letter. Consignees were instructed to located affected devices on hand, place the revised Operator's Manual with affected systems, remove and destroy the Operator s Manual that is presently with the Auryon Laser System, and notify any customers of the recall if the Auryon Laser System has been redistributed to another facility. Additionally, consignees were asked to complete and return the Reply Verification Tracking Form.
Recall details
- Recall number
- Z-0770-2025
- Status
- Open, Classified
- Initiated by the company
- Nov 25, 2024
- Posted by the FDA
- Dec 27, 2024
- Recalling firm
- Angiodynamics, Inc.
- Quantity
- 138 units
- Product code
- MCW
- FDA submissions
- K241553
- Distribution
- 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.
Product description
AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100
Code information (models, lots, serial numbers)
Product Number: EXM-2001-1100, Model Number: EXM001. UDI-DI: 07290017590110, Serial Number: EXM XXX.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Auryon Laser System 100-120 Vac EXM-2001-1100Eximo Medical Ltd · Catheter, Peripheral, Atherectomy1 recall0 reports
Other devices under the same FDA submission
1 device cleared under K241553 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Auryon Atherectomy Catheter EXM-4012-H000Eximo Medical Ltd · Catheter, Peripheral, Atherectomy2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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