Exact FDA event identifier

Event 63336

3 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: September 17, 2012
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Boston Scientific Corporation

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

3 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 3

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.

Z-0079-2013

Recall number: Z-0079-2013
Initiated: September 17, 2012
Classification: Class II
Status: Terminated
Recalling firm: Boston Scientific Corporation
Quantity: 19, 716 total all units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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.

Distribution pattern

Distributed in Brazil, Portugal and Hong Kong.

device · product 2 of 3

Leveen Coaccess Needle Electrode (3.5/15) and (4.0/15). 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.

Z-0080-2013

Recall number: Z-0080-2013
Initiated: September 17, 2012
Classification: Class II
Status: Terminated
Recalling firm: Boston Scientific Corporation
Quantity: 19,716 units distributed total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Code information

Material Catalog Number: MOO1262230 with lot numbers: 12293473, 12580337, 12639146, 12639181, 12642715,12647752,12651931,12653869, 12656587, 12663028, 12663626, 12667129, 12667787, 12741165, 12760565, 12799352, 12825090, 12849385, 12860811, 12895401, 12967872, 13002918, 13058416, 13096459, 13120668, 13166239, 13235239, 13309477, 13383272, 13399503, 13418415, 13463515, 13498936, 13545732, 13559348, 13665665, 13775008, 13805295, 13822358, 13872667, 13902427, 14076298, 14119776, 14131133, 14169885, 14206936, 14279112, and 14288333. Material Catalog Number: MOO1262240 with lot numbers: 12341198, 12341781, 12348901, 12351784, 12533460,12533461,12533466,12533467, 12533468, 12600849, 12642716, 12651932, 12663627, 12663628, 12663629, 12667788, 12674036, 12674312, 12741166, 12771577, 12805833, 12805835, 12860812, 12876589, 12937149, 12953904, 12982469, 13020096, 13048075, 13075112, 13117330, 13169619, 13230606,13247208, 13254418, 13278009, 13299117, 13309317, 13352191, 13384075, 13415014,13476371, 13480767, 13545557, 13592399, 13605018, 13610851, 13677260, 13727387,13775007, 13798432, 13813580, 13822357,13837691, 13873878, 13875213, 13883193, 13883196, 13936544, 13940480, 13978762,14076299, 14096255, 14157926, 14169886,14169887, 14217955, and 14249334.

Distribution pattern

Distributed in Brazil, Portugal and Hong Kong.

device · product 3 of 3

Leveen Coaccess Introducer Set. 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.

Z-0081-2013

Recall number: Z-0081-2013
Initiated: September 17, 2012
Classification: Class II
Status: Terminated
Recalling firm: Boston Scientific Corporation
Quantity: 19,716 units distributed total all products

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Code information

Material Catalog Number: MOO1262250 with lot numbers: 12303537, 12304530, 12318677, 12376281, 12516197, 12526599, 12564932, 12863427, 12868931, 12900282, 13020097, 13075108, 13093464, 13131129, 13364410, 13487647, 13488797, 13489157, 13563682, 13600249, 13629070, 13659872, 13759829, 13767726, 13892916, 14024827, 14119996, 14141754, 14215317, 14218162, 14218163, 14218164, 14268381, and 14273987.

Distribution pattern

Distributed in Brazil, Portugal and Hong Kong.