Recall Z-0770-2025
Angiodynamics, Inc. · initiated November 25, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100
Codes / lots: Product Number: EXM-2001-1100, Model Number: EXM001. UDI-DI: 07290017590110, Serial Number: EXM XXX.
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: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-0770-2025
- Initiated
- November 25, 2024
- Posted by FDA
- December 27, 2024
- Product code
- MCW – Catheter, Peripheral, Atherectomy
- Quantity
- 138 units
- 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.
- Recalling firm
- Angiodynamics, Inc., Queensbury, NY