Z-0770-2025 Class II Ongoing
FDA device recall Z-0770-2025 was initiated by Angiodynamics, Inc. on November 25, 2024 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 138 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 8, 2025
- Initiation Date
- November 25, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 138 units
Product Description
AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100
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.
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.
Code Information
Product Number: EXM-2001-1100, Model Number: EXM001. UDI-DI: 07290017590110, Serial Number: EXM XXX.