510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
Z-1913-2008

Boston Scientific LeVeen SuperSlim Needle Electrode, 2.0 cm/15 cm, sterile, Boston Scientific, Spencer, IN...

Boston Scientific Corporation / initiated 2008-04-30 / Terminated / root cause: design
FDA source (opens on fda.gov)

Boston Scientific Corp began a recall of 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... on . The reason FDA records is "The cannula may become detached from its correct orientation inside the handle and may prevent retraction of the tines". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-1913-2008
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Boston Scientific Corporation
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.
Product code
GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall
The cannula may become detached from its correct orientation inside the handle and may prevent retraction of the tines.
Root cause tag
design
FDA root cause
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.
Product codes and lots
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.)