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U.S. Department of Health and Human Services

Class 2 Device Recall AURYON LASER SYSTEM

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 Class 2 Device Recall AURYON LASER SYSTEMsee related information
Date Initiated by FirmNovember 25, 2024
Date PostedDecember 27, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0770-2025
Recall Event ID 95640
510(K)NumberK241553 
Product Classification Catheter, peripheral, atherectomy - Product Code MCW
ProductAURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100
Code Information Product Number: EXM-2001-1100, Model Number: EXM001. UDI-DI: 07290017590110, Serial Number: EXM XXX.
FEI Number 1319211
Recalling Firm/
Manufacturer		 Angiodynamics, Inc.
603 Queensbury Ave
Queensbury NY 12804-7619
For Additional Information ContactDavid Greer
518-795-1676
Manufacturer Reason
for Recall		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 Determined
Cause 2		Under Investigation by firm
ActionAngioDynamics 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.
Quantity in Commerce138 units
DistributionUS 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = MCW
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