Z-0739-2012

VenaCureEVLT Perforator Vein Ablation Kit, CATALOG #: EVLT/PVAK, STERILE -- Manufactured for: AngioDynamics...

Name: Z-0739-2012 VenaCureEVLT Perforator Vein Ablation Kit, CATALOG #: EVLT/PVAK, STERILE -- Manufactured for: AngioDynamics...
Creator: Angiodynamics Worldwide Headquarters
Published: 2011-12-06
License: https://open.fda.gov/license/

Angiodynamics Worldwide Headquarters / initiated 2011-12-06 / Terminated / root cause: labeling and UDI

FDA source

Angiodynamics Worldwide Headquarters began a recall of VenaCureEVLT Perforator Vein Ablation Kit, CATALOG #: EVLT/PVAK, STERILE -- Manufactured for: AngioDynamics Inc. 603 Queensbury, NY 12804 USA, AngioDynamics UK... on 2011-12-06. The reason FDA records is "The product was labeled with a specific indication for the treatment of perforator veins and this specific indication had not received FDA clearance prior to the product being marketed in the US". 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-0739-2012
Status: Terminated
Initiated: 2011-12-06
Posted: 2012-01-13
Terminated: 2016-02-05
Recalling firm: Angiodynamics Worldwide Headquarters
Product: VenaCureEVLT Perforator Vein Ablation Kit, CATALOG #: EVLT/PVAK, STERILE -- Manufactured for: AngioDynamics Inc. 603 Queensbury, NY 12804 USA, AngioDynamics UK Limited, Building 2000, Beach Drive, IQ Cambridge, Waterbeach, Cambridge, CB259TE, United Kingdom --- COMMON/USUAL NAME: Laser Surgical Instrument; CLASSIFICATION NAME: Powered Laser Surgical Instrument; DEVICE LISTING # D053485. --- Product Usage: The 810nm Diomed Laser and EVLT Procedure Kit are intended for use in the treatment of superficial vein reflux of the greater saphenous vein associated with varicosities. The Diomed D15 plus and D30 plus and EVLT Kits are indicated for treatment of incompetence and reflux of superficial veins in the lower extremity.
Product code: GEX Powered Laser Surgical Instrument
Reason for recall: The product was labeled with a specific indication for the treatment of perforator veins and this specific indication had not received FDA clearance prior to the product being marketed in the US.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Angiodynamics sent an Urgent Medical Device Recall Letters and Response Forms dated December 2, 2011 to all affected consignees via Certified Mail on December 6, 2011. The recall was extended to the medical user level. The letter identified the product, problem, and actions to be taken. Customers were instructed not to use the product and to return recalled product to AngioDynamics, Inc. in Queensbury, NY. The letter states if the affected product/lot have been distributed, please inform your customers of this recall action immediately and have them return the recalled units. For questions or concerns call the Customer Service Manager at ANGIODYNAMICS Customer Service at 1-800-722-6446.
Quantity in commerce: 7640 units domestically
Distribution: (USA) Nationwide Distribution
Product codes and lots: Batch/Lot Numers: 005813A, 005813B, 005854, 005854A, 005855, 005856, 005903, 005904, 005905, 005918, 005919, 005920, 005921, 005922, 005929, 005930, 005931, 005932, 005933, 005942, 005943, 005944, 005945, 005946, 005947, 005948, 005966, 005967, 005968, 005969, 005970

Product code GEX

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)