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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 Electrodesee related information
Date Initiated by FirmOctober 01, 2007
Date PostedSeptember 16, 2008
Recall Status1 Terminated 3 on September 16, 2008
Recall NumberZ-2091-2008
Recall Event ID 48437
510(K)NumberK982556 
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
ProductBoston Scientific LeVeen SuperSlim Needle Electrode, 2.0 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
ActionCustomer 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 Commerce15,604 of all products
DistributionJapan.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = GEI
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