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Open, Classified

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

FDA Recall Z-0770-2025 · Posted 2024-12-27

Recalling FirmAngiodynamics, Inc.
Recall StatusOpen, Classified
Product CodeMCW
Date Initiated2024-11-25
Product Quantity138 units

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.

Firm Action

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.

Root Cause

Under Investigation by firm

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K241553Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic CoatingEximo Medical, Ltd. · 2024-06-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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