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U.S. Department of Health and Human Services

Class 2 Device Recall LeVeen Coaccess Introducer Set

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  Class 2 Device Recall LeVeen Coaccess Introducer Set see related information
Date Initiated by Firm September 17, 2012
Date Posted October 18, 2012
Recall Status1 Terminated 3 on July 17, 2013
Recall Number Z-0081-2013
Recall Event ID 63336
510(K)Number K012315  
Product Classification Electrode, electrosurgical - Product Code JOS
Product Leveen Coaccess Introducer Set.

Disposable, monopolar, electrosurgical devices, intended for use in conjunction with BSC radiofrequency generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.
Code Information Material Catalog Number: MOO1262250 with lot numbers: 12303537, 12304530, 12318677, 12376281, 12516197, 12526599, 12564932, 12863427, 12868931, 12900282, 13020097, 13075108, 13093464, 13131129, 13364410, 13487647, 13488797, 13489157, 13563682, 13600249, 13629070, 13659872, 13759829, 13767726, 13892916, 14024827, 14119996, 14141754, 14215317, 14218162, 14218163, 14218164, 14268381, and 14273987.
Recalling Firm/
Boston Scientific Corporation
100 Boston Scientific Way
Marlborough MA 01752-1234
Manufacturer Reason
for Recall
Leveen Standard and Leveen Coaccess Needle Electrode System, Directions for Use(DFU) in Portuguese, are incorrect. all other languages in the DFU are correct. Consignees in Brazil, Portugal,and Hong-Kong are being notified.
FDA Determined
Cause 2
Labeling Change Control
Action Boston Scientific sent notifications, dated September 17, 2012, to each account in Brazil, Portugal and Hong Kong affected by the recall. The affected accounts were provided the corrected pages of the Portuguese DFU as part of the communication to ensure that those users that rely on the Portuguese DFU have the correct information.
Quantity in Commerce 19,716 units distributed total all products
Distribution Distributed in Brazil, Portugal and Hong Kong.
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 = JOS and Original Applicant = RADIOTHERAPEUTICS CORP.