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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 October 01, 2007
Date Posted September 16, 2008
Recall Status1 Terminated 3 on September 16, 2008
Recall Number Z-2093-2008
Recall Event ID 48437
510(K)Number K982556  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product Boston Scientific LeVeen SuperSlim Needle Electrode, 3.0 cm/15 cm, sterile. The device is intended to be used in conjunction with a Radio Therapeutics Corporation radiofrequency (RF) generator for thermal coagulation necrosis of soft tissue, including partial or complete ablation of nonresectable liver lesions.
Code Information All lots.
Recalling Firm/
Manufacturer		 Boston Scientific Corp
780 Brookside Dr
Spencer IN 47460-1080
For Additional Information Contact
508-683-4000
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 Customer notifications were sent to customers in Japan on October 1, 2007 instructing them to check their inventory and to return affected product. Contact Rob Miragliuolo at 508-683-4186 if you have questions.
Quantity in Commerce 15,604 of all products
Distribution Japan.
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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