—#195924

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.

FDA product code: GEX — Powered Laser Surgical Instrument
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K041957
Affected lot / code info: UDI-DI: 25051684014653 UPN: H787EVLT55OPS5 Lot Number: 5728621

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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

Recalling firm

Firm: Angiodynamics, Inc.
Address: 603 Queensbury Ave, Queensbury, New York 12804-7619

Distribution

Distribution pattern: US Nationwide distribution in the states of FL, NC, NJ, NM, NY, PA, TX, VA.

Timeline

Recall initiated: 2022-08-10
Posted by FDA: 2022-09-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #195924. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.