—#113533

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.

FDA product code: JOS — Electrode, Electrosurgical
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K012315
Affected lot / code info: 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.

Why it was recalled

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 (FDA determination)

Labeling Change Control

Action the firm took

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.

Recalling firm

Firm: Boston Scientific Corporation
Address: 100 Boston Scientific Way, Marlborough, Massachusetts 01752-1234

Distribution

Distribution pattern: Distributed in Brazil, Portugal and Hong Kong.

Timeline

Recall initiated: 2012-09-17
Posted by FDA: 2012-10-18
Terminated: 2013-07-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #113533. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.