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U.S. Department of Health and Human Services

Class 2 Device Recall LeVeen

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  Class 2 Device Recall LeVeen see related information
Date Initiated by Firm July 29, 2005
Date Posted September 14, 2005
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = RADIOTHERAPEUTICS CORP.
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