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U.S. Department of Health and Human Services

Class 2 Device Recall LeVeen Needle Electrode

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  Class 2 Device Recall LeVeen Needle Electrode see related information
Date Initiated by Firm July 06, 2009
Date Posted September 09, 2009
Recall Status1 Terminated 3 on October 08, 2010
Recall Number Z-1876-2009
Recall Event ID 52659
510(K)Number K000032  
Product Classification tissue coagulation - Product Code GEI
Product Boston Scientific, LeVeen Needle Electrode, 15 cm, 5.0 cm, sterile; REF M001262160. For tissue coagulation.
Code Information Lots 8745076, 8745077, 8745078, 8745082, 8745083, 8764662, 8764663, 8840136, 8840210, 8888632, 8922046, 8922047, 8922048, 8925499, 8946944, 8952359, 8960112, 8991516, 9007921, 9023847, 9051903, 9063250, 9080980, 9103385, 9103712, 9103713, 9103714, 9135758, 9153911, 9160547, 9275203, 9288929, 9300199, 9303597, 9406392, 9447228, 9464347, 9484064, 9502208, 9516123, 9591056, 9629225, 9643197, 9659590, 9708545, 9727738, 9763201, 9776097, 9783671, 11001461, 11005784, 11034758, 11042785, 11091132, 11114016, 11128377, 11128379, 11178425, 11203868, 11230657, 11356155, 11403788, 11440970, 11460060, 11551315, 11580328, 11620899, 11711276, 11766589, 11851200, 11881851, 11900344, 11916630, 11931597, 11943359, 11947005, 12324021, 12450298, 12517661 and 12621268. 
Recalling Firm/
Manufacturer		 Boston Scientific Corp
780 Brookside Dr
Spencer IN 47460-1080
For Additional Information Contact
508-683-4678
Manufacturer Reason
for Recall		 The tines may detach from the core wire during use, which may result in bleeding or soft tissue trauma requiring medical intervention.
FDA Determined
Cause 2		 Process control
Action Boston Scientific notified consignees by letter dated 7/6/09 and instructed to cease using and to return the products, and to complete and return a reply form.
Quantity in Commerce 2,774
Distribution Nationwide.
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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