| Class 2 Device Recall LeVeen Needle Electrode | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = GEI
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