Z-0079-2013Class II

LeVeen Standard Needle Electrode System, Sterile (3.5/12), (3.5/15), (4.0/15), (3.5/25), (5.0/15), (5.0/25)...

Name: Z-0079-2013 LeVeen Standard Needle Electrode System, Sterile (3.5/12), (3.5/15), (4.0/15), (3.5/25), (5.0/15), (5.0/25)...
Creator: Boston Scientific Corporation
Published: 2012-09-17
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2012-09-17 / Terminated / root cause: labeling and UDI

FDA source

Boston Scientific Corporation began a recall of 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... on 2012-09-17. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0079-2013
Classification: Class II
Status: Terminated
Initiated: 2012-09-17
Posted: 2012-10-18
Terminated: 2013-07-17
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.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
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.
Root cause tag: labeling and UDI
FDA 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 in commerce: 19, 716 total all units
Distribution: Distributed in Brazil, Portugal and Hong Kong.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0079-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0079-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-24	2012-10-18
Z-0080-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-24	2012-10-18
Z-0081-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-24	2012-10-18

Product code GEI

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)