Recall Z-0079-2013 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Boston Scientific Corporation
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.
| Date | Oct 18, 2012 (initiated Sep 17, 2012) |
| Status | Terminated |
| 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. |
| 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 | 19, 716 total all units |
| Distribution | Distributed in Brazil, Portugal and Hong Kong. |
| FDA record | Open on fda.gov |