Z-0413-2012

VenaCure EVLT NeverTouch-FRS PROCEDURE KIT Featuring Gold-Tipped Fiber, 65 cm, VenaCure NeverTouch FRS 65cm...

Name: Z-0413-2012 VenaCure EVLT NeverTouch-FRS PROCEDURE KIT Featuring Gold-Tipped Fiber, 65 cm, VenaCure NeverTouch FRS 65cm...
Creator: Angiodynamics Worldwide Headquarters
Published: 2011-11-10
License: https://open.fda.gov/license/

Angiodynamics Worldwide Headquarters / initiated 2011-11-10 / Terminated / root cause: manufacturing process

FDA source

Angiodynamics Worldwide Headquarters began a recall of VenaCure EVLT NeverTouch-FRS PROCEDURE KIT Featuring Gold-Tipped Fiber, 65 cm, VenaCure NeverTouch FRS 65cm Clear Needle, Catalog No./REF 51403002, STERILE --... on 2011-11-10. The reason FDA records is "During an in-process inspection the hemostasis sidearm assemblies were identified to have the potential for flash to exist on the housing at the base of the threads. This flash has the potential to break off and...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0413-2012
Status: Terminated
Initiated: 2011-11-10
Posted: 2012-01-11
Terminated: 2016-02-01
Recalling firm: Angiodynamics Worldwide Headquarters
Product: VenaCure EVLT NeverTouch-FRS PROCEDURE KIT Featuring Gold-Tipped Fiber, 65 cm, VenaCure NeverTouch FRS 65cm Clear Needle, Catalog No./REF 51403002, STERILE -- AngioDynamics, Inc. 603 Queensbury, NY USA 12804. This is a Special Order. Product Usage: The AngioDynamics, Inc. VenaCure Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity.
Product code: GEX Powered Laser Surgical Instrument
Reason for recall: During an in-process inspection the hemostasis sidearm assemblies were identified to have the potential for flash to exist on the housing at the base of the threads. This flash has the potential to break off and relocate within the fluid path.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: AngioDynamics sent an URGENT: Medical Device Recall letters and response form (dated November 10, 2011) to all affected customers. The letter identified the affected products, the problem, and the actions to be taken by customer/user. The customers were instructed to do the following: 1) Identify, segregate and return the recalled products to ANGIODYNAMICS and 2) Complete the enclosed Recall Reply Form even if they do not have any products remaining in their possession, noting zero quantity to be returned and fax to 518-798-1360. The letter states that a returned authorization number (RA#) will be assigned to each customer in the recall notification letter, an UPS account will be provided for return freight and a replacement product will be shipped upon receipt and confirmation of the returned product. If you have any additional questions or concerns or need more detailed instruction on how to comply with this notice, please do not hesitate to contact your local sales representative or call the Customer Service Manager, at ANGIODYNAMICS Customer Service at 1-800-772-6446. You may also e-mail your questions to [email protected].
Quantity in commerce: 186 units
Distribution: Worldwide Distribution - USA (nationwide) and the countries of: Canada, Great Britain, France, India, New Zealand, Netherlands, Saudi Arabia, Turkey, and Singapore
Product codes and lots: Batch/Lot Numbers: 551253, 553312, 554789

Product code GEX

K102796Class IIAngiodynamics, Inc. Venacure Procedure KitAngioDynamics, Inc. / cleared 2010-12-15

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)