| Class 2 Device Recall Boston Scientific LeVeen SuperSlim Needle Electrode | |
Date Initiated by Firm | April 30, 2008 |
Date Posted | September 11, 2008 |
Recall Status1 |
Terminated 3 on August 04, 2009 |
Recall Number | Z-1913-2008 |
Recall Event ID |
48079 |
510(K)Number | K982556 |
Product Classification |
Electrosurgical, cutting, and coagulation accessory - Product Code GEI
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Product | Boston Scientific LeVeen SuperSlim Needle Electrode, 2.0 cm/15 cm, sterile, Boston Scientific, Spencer, IN; REF 26-226, UPN M001262260. The product is used with a radiofrequency generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions. |
Code Information |
All lots. (Lots 0007754221, 0007756536, 0007760602, 0007773373, 0007773795, 0007795354, 0007795671, 0007829946, 0007860541, 0007924564, 0007929069, 0007935435, 0007935641, 0007935927, 0007967967, 0007973448, 0007973449, 0007983095, 0007999035, 0008029591, 0008029965, 0008047351, 0008055911, 0008100038, 0008100039, 0008119923, 0008119924, 0008138446, 0008142890, 0008142891, 0008147540, 0008165769, 0008165770, 0008165771, 0008181500, 0008198428, 0008198430, 0008202143, 0008229896, 0008246451, 0008246452, 0008247161, 0008250918, 0008250919, 0008262976, 0008262977, 0008279250, 0008287295, 0008632162, 0008633030, 0008678724, 0008715160, 0008745079, 0008745080, 0008745081, 0008745084, 0008745085, 0008757525, 0008764755, 0008815843, 0008815844, 0008840208, 0008842737, 0008843687, 0008855834, 0008865948, 0008870965, 0008885317, 0008922049, 0008922050, 0008922051, 0008962320, 0008971482, 0008976593, 0008993095, 0009012204, 0009012205, 0009012206, 0009034730, 0009059144, 0009070216, 0009081512, 0009092663, 0009103629, 0009103630, 0009103631, 0009104111, 0009275204, 0009277201, 0009277202, 0009288930, 0009292225, 0009294911, 0009295272, 0009295273, 0009330954, 0009344590, 0009352769, 0009386363, 0009409068, 0009429873, 0009449403, 0009457082, 0009464931, 0009488649, 0009501969, 0009520948, 0009538053, 0009554399, 0009568323, 0009595705, 0009595853, 0009609675, 0009622354, 0009645946, 0009662038, 0009679969, 0009696743, 0009711986, 0009726408, 0009726409, 0009731711, 0009747000, 0009749812, 0009776800, 0009784043, 0009800139, 0011001910, 0011007735, 0011017381, 0011027710, 0011036114, 0011042782, 0011083691, 0011111662, 0011300194, 0011303965, 0011312752 and 0011442784.) |
Recalling Firm/ Manufacturer |
Boston Scientific Corp 780 Brookside Dr Spencer IN 47460-1080
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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 | 7,460 |
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 |
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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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