FDA Device recall Z-0081-2013
Leveen Coaccess Introducer Set
- FDA Device
- Class II
- terminated
- Published 2012-10-24
On 2012-10-24 the FDA classified a Class II recall of Leveen Coaccess Introducer Set by Boston Scientific, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0081-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-09-17 |
| Published | 2012-10-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Boston Scientific |
| Distribution | n/a |
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.
Reason
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.
Identifiers
| code_info | Material Catalog Number: MOO1262250 with lot numbers: 12303537, 12304530, 12318677, 12376281, 12516197, 12526599, 12564…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0081-2013%22
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