FDA Enforcement
Class II
Ongoing
AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100
Recall: Z-0770-2025
·
Reported January 8, 2025
Enforcement
- Recall Number
- Z-0770-2025
- Event ID
- 95640
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Angiodynamics, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 8, 2025
- Initiation Date
- November 25, 2024
- Classification Date
- December 27, 2024
- Address
- 603 Queensbury Ave, Queensbury, NY, 12804-7619, United States
Description
AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100
Reason
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.
Code Info
Product Number: EXM-2001-1100, Model Number: EXM001. UDI-DI: 07290017590110, Serial Number: EXM XXX.
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.
Quantity
138 units