Z-1819-2022Class II

VenaCure EVLT KIT WITH SPOTLIGHT OPS SHEATH 55CM Ref./ Catalog No.: EVLT55OPS (each box contains 5 Procedure...

Name: Z-1819-2022 VenaCure EVLT KIT WITH SPOTLIGHT OPS SHEATH 55CM Ref./ Catalog No.: EVLT55OPS (each box contains 5 Procedure...
Creator: Angiodynamics, Inc.
Published: 2022-08-10
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2022-08-10 / Open, Classified / root cause: packaging

FDA source

Angiodynamics, Inc. began a recall of 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 on 2022-08-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1819-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-08-10
Posted: 2022-09-27
Recalling firm: Boston Scientific Corporation
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.
Product code: GEX Powered Laser Surgical Instrument
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
Root cause tag: packaging
FDA root 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): [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
Quantity in commerce: 40 units
Distribution: US Nationwide distribution in the states of FL, NC, NJ, NM, NY, PA, TX, VA.
Product codes and lots: UDI-DI: 25051684014653 UPN: H787EVLT55OPS5 Lot Number: 5728621

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1819-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1819-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-10-05	2022-09-27

Product code GEX

K041957Class IIEvlt Kit and the D15plus and D30plus Diode LasersDiomed, Inc. / cleared 2004-12-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)