Z-0081-2013Class II

Leveen Coaccess Introducer Set. Disposable, monopolar, electrosurgical devices, intended for use in...

Name: Z-0081-2013 Leveen Coaccess Introducer Set. Disposable, monopolar, electrosurgical devices, intended for use in...
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 Coaccess Introducer Set. Disposable, monopolar, electrosurgical devices, intended for use in conjunction with BSC radiofrequency generator for the... 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-0081-2013
Classification: Class II
Status: Terminated
Initiated: 2012-09-17
Posted: 2012-10-18
Terminated: 2013-07-17
Recalling firm: Boston Scientific Corporation
Product: Leveen 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.
Product code: JOS Electrode, Electrosurgical
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 units distributed total all products
Distribution: Distributed in Brazil, Portugal and Hong Kong.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0081-2013
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 JOS

K012315Class IILeveen ElectrodeRadiotherapeutics Corp. / cleared 2001-10-11

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)