Recall Z-0770-2025— Angiodynamics, Inc.

Name: FDA recall Z-0770-2025
Creator: U.S. Food and Drug Administration
Published: 2024-11-25

Class II · Ongoing

Class II FDA medical device recall by Angiodynamics, Inc., initiated 2024-11-25. It names one FDA 510(k) clearance: K241553. Product: 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..

Recalling firm: Angiodynamics, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2024-11-25
Firm location: Queensbury, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K241553 — Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic CoatingEximo Medical, Ltd.·cleared 2024-06-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.