Z-2444-2019Class II

AngioDynamics VenaCure EVLT NeverTouch Procedure Kit, 45CM NEVERTOUCH FRS .018 PROCEDURE KIT PG, Catalog...

Name: Z-2444-2019 AngioDynamics VenaCure EVLT NeverTouch Procedure Kit, 45CM NEVERTOUCH FRS .018 PROCEDURE KIT PG, Catalog...
Creator: Angiodynamics, Inc.
Published: 2019-06-27
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2019-06-27 / Terminated / root cause: labeling and UDI

FDA source

Angiodynamics, Inc. began a recall of AngioDynamics VenaCure EVLT NeverTouch Procedure Kit, 45CM NEVERTOUCH FRS .018 PROCEDURE KIT PG, Catalog Number 11403012 on 2019-06-27. FDA classified it as Class II and gives the reason as "The affected product is properly labelled with an expiration date of March 31, 2022; but the RFID programmed expiration date is April-2014 which results in an error message when connected to the laser source and...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2444-2019
Classification: Class II
Status: Terminated
Initiated: 2019-06-27
Posted: 2019-08-30
Terminated: 2020-07-29
Recalling firm: Boston Scientific Corporation
Product: AngioDynamics VenaCure EVLT NeverTouch Procedure Kit, 45CM NEVERTOUCH FRS .018 PROCEDURE KIT PG, Catalog Number 11403012
Product code: GEX Powered Laser Surgical Instrument
Reason for recall: The affected product is properly labelled with an expiration date of March 31, 2022; but the RFID programmed expiration date is April-2014 which results in an error message when connected to the laser source and prevents the product from being used.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Customers were contacted via telephone on 6/27/19 directing them to stop using the affected product and segregate until receipt of written Recall Notification. Urgent Voluntary Medical Device Recall notification letters were sent to customers on July 2, 2019.
Quantity in commerce: 109
Distribution: The products were distributed to the following US states: DC, IL, IN, MI, NJ, TN, TX, and WI.
Product codes and lots: Lot 5456490; UPN H787114030120

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2444-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2444-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-11	2019-08-30

Product code GEX

K112600Class IIAngiodynamics, Inc. Venacure Nevertouch Direct Procedure KitAngioDynamics, Inc. / cleared 2012-01-30

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)