Class 2 Device Recall AngioDynamics

• Date Initiated by Firm: August 10, 2022
• Date Posted: September 27, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1819-2022
• Recall Event ID: 90811
• 510(K)Number: K041957
• Product Classification: Powered laser surgical instrument - Product Code GEX
• Product: VenaCure EVLT KIT WITH SPOTLIGHT OPS SHEATH 55CM Ref./ Catalog No.: EVLT55OPS (each box contains 5 Procedure Kits). For use in the treatment of varicose veins.
• Code Information: UDI-DI: 25051684014653 UPN: H787EVLT55OPS5 Lot Number: 5728621
• Recalling Firm/ Manufacturer: Angiodynamics, Inc.; 603 Queensbury Ave; Queensbury NY 12804-7619
• For Additional Information Contact: SAME; 518-798-1215
• Manufacturer Reason for Recall: OPS Fiber packaged within specific VenaCure EVLT Procedure Kits does not meet the required dimensional specification, may result in damage to the sheath, including separation or the inability to move the fiber within the sheath. A damaged sheath will necessitate removal from the patient, which may result in procedural delay and/or surgical intervention
• FDA Determined Cause: Under Investigation by firm
• Action: AngioDynamics, Inc, issued Urgent Voluntary Medical Device Recall letter dated 8/10/22 via Federal Express states reason for recall, health risk and action to take: 1. Actions to be taken: IMMEDIATELY o Stop using the product subject to recall. o Remove any affected (recalled) product from your inventory (whether in labs, Central Supply, Shipping and Receiving or ANY other location). o Segregate this product in a secure location for return to AngioDynamics, Inc. o Forward a copy of this recall notification to all sites to which you have distributed affected product. 2. Complete and return the Reply Verification Tracking Form. If affected product is located in your institution, please call AngioDynamics Customer Service at 1 800 772 6446 between 8:00 a.m. and 7:00 p.m. (Monday Friday: Eastern Standard Time) to obtain a replacement or credit for your returned product. Promptly complete, sign, and return the enclosed Reply Verification Tracking Form (even if you do not have any product to return); following the directions on this page and the Reply Verification Tracking Form. Email Reply Verificaon Tracking Form (preferred): recall@angiodynamics.com Fax Reply Verificaon Tracking Form: Attn: VenaCure EVLT 55cm Fiber Recall Coordinator Fax number 1 855 273 0519 3. Package and Return the Recalled Product. Package any product that is being returned in an appropriate shipping box. Write the RMA number on the RMA/Address label (provided on the Recall Verification Tracking Form) and affix the label to the outside of the shipping box. Seal the box and return to: AngioDynamics, Inc. 24 Native Drive Queensbury, NY 12804 Attn: VenaCure EVLT 55cm Fiber Recall Coordinator
• Quantity in Commerce: 40 units
• Distribution: US Nationwide distribution in the states of FL, NC, NJ, NM, NY, PA, TX, VA.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = GEX