Boston Scientific Corporation: Medical Device Recall in 2012 - (Recall #: Z-0081-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: September 17, 2012

Date Posted: October 24, 2012

Recall Number: Z-0081-2013

Event ID: 63336

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.

Status: Terminated

Product Quantity: 19,716 units distributed total all products

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.

Voluntary or Mandated:

Voluntary: Firm initiated