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VenaCure EVLT KIT WITH SPOTLIGHT OPS SHEATH 55CM recallZ-1819-2022 · Angiodynamics, Inc. · initiated Aug 10, 2022

Class II Open, Classified All recalls posted in September 2022

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Angiodynamics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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

FDA root cause category: Under Investigation by firm

What the company is doing

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): [email protected] 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

Recall details

Recall number
Z-1819-2022
Recall class
Class II
Status
Open, Classified
Initiated by the company
Aug 10, 2022
Posted by the FDA
Sep 27, 2022
Recalling firm
Angiodynamics, Inc.
Quantity
40 units
Product code
GEX
FDA submissions
K041957
Distribution
US Nationwide distribution in the states of FL, NC, NJ, NM, NY, PA, TX, VA.

Product description

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 (models, lots, serial numbers)

UDI-DI: 25051684014653 UPN: H787EVLT55OPS5 Lot Number: 5728621

Other devices under the same FDA submission

4 devices cleared under K041957 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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