Angiodynamics, Inc.: Device Recall
Recall #Z-0770-2025 · 11/25/2024
Class II: Risk
Recall Details
- Recall Number
- Z-0770-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Angiodynamics, Inc.
- Status
- Ongoing
- Date Initiated
- 11/25/2024
- Location
- Queensbury, NY, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 138 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.
Product Description
AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100
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.
Other Recalls by Angiodynamics, Inc.
- Class II: Risk 02/04/2025
- Class II: Risk 06/18/2024
- Class II: Risk 06/18/2024
- Class II: Risk 05/21/2024
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.