Boston Scientific Corporation: LeVeen Standard Needle Electrode System, Sterile (3.5/12), (3.5/15), (4.0/15), (3.5/25), (5.0/15), (5.0/25), and (4.0/25). Disposable, monopolar, electrosurgical devices, intended for use in conjunction with BSC radiofrequency generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.

Recall number

Z-0079-2013

Recalling firm

Boston Scientific Corporation

Product

LeVeen Standard Needle Electrode System, Sterile (3.5/12), (3.5/15), (4.0/15), (3.5/25), (5.0/15), (5.0/25), and (4.0/25). Disposable, monopolar, electrosurgical devices, intended for use in conjunction with BSC radiofrequency generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.

Status

Terminated

Initiated

2012-09-17

Posted

2012-10-18

Terminated

2013-07-17

Reason

Leveen Standard and Leveen Coaccess Needle Electrode System, Directions for Use(DFU) in Portuguese, are incorrect. all other languages in the DFU are correct. Consignees in Brazil, Portugal,and Hong-Kong are being notified.

Root cause

Labeling Change Control

Action

Boston Scientific sent notifications, dated September 17, 2012, to each account in Brazil, Portugal and Hong Kong affected by the recall. The affected accounts were provided the corrected pages of the Portuguese DFU as part of the communication to ensure that those users that rely on the Portuguese DFU have the correct information.

Quantity

19, 716 total all units

Distribution

Distributed in Brazil, Portugal and Hong Kong.

Lot, serial or model codes

Material Catalog Number: MOO1262020 with lot number 12328876, 12334483, 12476383, 12647754, 12820081,13226500,13794799,14056980, to 14256254   Material Catalog Number: MOO1262030 with lot numbers: 12070030,12232431, 12304529, 12358495,12366221, 12369009, 12443954, 12468608, 12513817, 12517660, 12519936, 12531020, 12554485,12596138, 12596139, 12597262, 12623130, 12639148, 12671011, 12684019,12684060, 12716783, 12739190, 12739191, 12752512, 12776061, 12777406,12800414, 12827364, 12827366, 12859848, 12918329, 12964088, 12981359,13147376, 13234686, 13247035, 13268344, 13545733, 13775010, 13797846,13895190, 14026691, 14189753, and 14296363.  Material Catalog Number: MOO1262130 with lot numbers: 12194570, 12236087, 12301525, 12347763, 12369928, 12388139, 12461730, 12471647, 12483794,12595989, 12639142, 12642528, 12645904,12686240, 12686241, 12703848, 12716782,12729308, 12752513, 12765053, 12779899,12809759, 12823345, 12936839, 13096620,13146630, 13184435, 13261587,13261588, 13309476, 13340305, 13352060, 13368435, 13415013, 13446383, 13463516, 13562255, 13687183, 13741706, 13756460, 13775011, 13883198, 13921931, 14024825, 14045969, 14056896, 14124437, 14152109, 14189752, and 14255475.  Material Catalog Number: MOO1262150 with lot numbers: 12461731, 12553201, 12613549, 12985137, 13125554, 13513953, 13562258, and 14045126.  Material Catalog Number: MOO1262160 with lot numbers: 11947005, 12324021, 12450298, 12517661, 12621268, 12759716, 12765307,12768372, 12791402, 12812889, 12825010, 12827365, 12838575, 12863428, 12866939, 12888444, 12922750, 12928251, 12928254, 12981358, 13015755, 13071900, 13253941, 13261457, 13261458, 13261459, 13451361, 13559353, 13654711, 13704659, 13793644, 14084357, and 14245022.  Material Catalog Number: MOO1262170 with lot numbers: 12475134, 12766168, 12813711, 12864618, 12928253, 12937147, 13052643, 13254409, 13476370, and 13605014.  Material Catalog Number: MOO1262310 with lot numbers: 12623121, 12722227, 13064473, 13254415, 13491966, 13580524, 13605081, 13797848, and 13973744.

510(k) numbers

["K000032","K982556"]

PMA numbers

not on file

Product code

GEI

Firm FEI

3005099803

Firm city

Marlborough

Firm state

MA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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