Device Recall VenaCureEVLT

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

General and Plastic Surgery Devices

2

No

(USA) Nationwide Distribution

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.