—#210863

Product

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

FDA product code: MCW — Catheter, Peripheral, Atherectomy
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K241553
Affected lot / code info: Product Number: EXM-2001-1100, Model Number: EXM001. UDI-DI: 07290017590110, Serial Number: EXM XXX.

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Angiodynamics, Inc.
Address: 603 Queensbury Ave, Queensbury, New York 12804-7619

Distribution

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.

Timeline

Recall initiated: 2024-11-25
Posted by FDA: 2024-12-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #210863. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.