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U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientific LeVeen SuperSlim Needle Electrode

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  Class 2 Device Recall Boston Scientific LeVeen SuperSlim Needle Electrode see related information
Date Initiated by Firm April 30, 2008
Date Posted September 11, 2008
Recall Status1 Terminated 3 on August 04, 2009
Recall Number Z-1914-2008
Recall Event ID 48079
510(K)Number K982556  
Product Classification Electrosurgical, cutting, and coagulation accessory - Product Code GEI
Product Boston Scientific LeVeen SuperSlim Needle Electrode, 2.0 cm/25 cm, sterile, Boston Scientific, Spencer, IN; REF 26-227, UPN M001262270. The product is used with radiofrequency generator for the thermal coagulation necrosis of soft tissues,including partial or complete ablation of nonresectable liver lesions.
Code Information All lots (Lots 0007754222, 0007757352, 0007774377, 0007778866, 0007787319, 0007802363, 0007819373, 0008025066, 0008033462, 0008119925, 0008126720, 0008139108, 0008167709, 0008187490, 0008189883, 0008191619, 0008272777, 0008274731, 0008301843, 0008900347, 0009106193, 0009261704, 0009261705, 0009261706, 0009275205, 0009292249, 0009344591, 0009382115, 0009422549, 0009437649, 0009446512, 0009464930, 0009505685, 0009532051, 0009569176, 0009595712, 0009647788, 0009663657, 0009749621, 0009783669, 0009799393, 0009993406 0011311216 and 0011517938.)
Recalling Firm/
Manufacturer		 Boston Scientific Corp
780 Brookside Dr
Spencer IN 47460-1080
For Additional Information Contact
866-868-4004
Manufacturer Reason
for Recall		 The cannula may become detached from its correct orientation inside the handle and may prevent retraction of the tines.
FDA Determined
Cause 2		 Device Design
Action Consignees were notified by recall letter on 4/30/08, sent fexex priority mail, to cease use of the products and to return them to the firm. For assistance, contact Boston Scientific at 1-508-683-4186.
Quantity in Commerce 1,356
Distribution Nationwide, Argentina, Belgium, Canada, Czech Republic, Egypt, Finland, France, Germany, Great Britain, Hong Kong, Hungary, Iraq, Ireland, Italy, Jordan, Korea, Lebanon, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, and United Arab Emirates.
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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