Class 2 Device Recall LeVeen

• Date Initiated by Firm: July 29, 2005
• Date Posted: September 14, 2005
• Recall Status: Terminated on December 08, 2005
• Recall Number: Z-1541-05
• Recall Event ID: 33089
• 510(K)Number: K982556
• Product Classification: Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
• Product: Boston Scientific brand LeVeen Needle Electrode, 5.0/13/15; Model number M001262160, Ref 26-216.
• Code Information: Lots 31804, 92702, 6538336, 6538341, 6556258, 6556462, 6556464, 6556634, 6826039, 7002067, 7021736, 7091482, 7108067, 7257089, 7356251, 7422492, 7457364, 7664972, 7667650, 21403R, 21703R and 92702R.
• Recalling Firm/ Manufacturer: Boston Scientific Corp; 780 Brookside Dr; Spencer IN 47460-1080
• For Additional Information Contact: Cindy Finney; 508-683-4678
• Manufacturer Reason for Recall: Firm has received complaints of extended ablation times, lack of roll-off and patient burns.
• FDA Determined Cause: Other
• Action: Distributors and user accounts were notified via medical device correction letter dated 7/29/05.
• Distribution: Nationwide, Australia, Brazil, Canada, Hong Kong, Netherlands, Panama, Singapore and Taiwan.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = GEI