Events

Retiro De Equipo (Recall) de LeVeen Standard Needle Electrode System

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Boston Scientific Corporation.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    63336
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0079-2013
  • Fecha de inicio del evento
    2012-09-17
  • Fecha de publicación del evento
    2012-10-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-07-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113516
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • Causa
    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.
  • Acción
    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.

Device

LeVeen Standard Needle Electrode System
  • Modelo / Serial
    Material Catalog Number: MOO1262020 with lot number 12328876, 12334483, 12476383, 12647754, 12820081,13226500,13794799,14056980, to 14256254   Material Catalog Number: MOO1262030 with lot numbers: 12070030,12232431, 12304529, 12358495,12366221, 12369009, 12443954, 12468608, 12513817, 12517660, 12519936, 12531020, 12554485,12596138, 12596139, 12597262, 12623130, 12639148, 12671011, 12684019,12684060, 12716783, 12739190, 12739191, 12752512, 12776061, 12777406,12800414, 12827364, 12827366, 12859848, 12918329, 12964088, 12981359,13147376, 13234686, 13247035, 13268344, 13545733, 13775010, 13797846,13895190, 14026691, 14189753, and 14296363.  Material Catalog Number: MOO1262130 with lot numbers: 12194570, 12236087, 12301525, 12347763, 12369928, 12388139, 12461730, 12471647, 12483794,12595989, 12639142, 12642528, 12645904,12686240, 12686241, 12703848, 12716782,12729308, 12752513, 12765053, 12779899,12809759, 12823345, 12936839, 13096620,13146630, 13184435, 13261587,13261588, 13309476, 13340305, 13352060, 13368435, 13415013, 13446383, 13463516, 13562255, 13687183, 13741706, 13756460, 13775011, 13883198, 13921931, 14024825, 14045969, 14056896, 14124437, 14152109, 14189752, and 14255475.  Material Catalog Number: MOO1262150 with lot numbers: 12461731, 12553201, 12613549, 12985137, 13125554, 13513953, 13562258, and 14045126.  Material Catalog Number: MOO1262160 with lot numbers: 11947005, 12324021, 12450298, 12517661, 12621268, 12759716, 12765307,12768372, 12791402, 12812889, 12825010, 12827365, 12838575, 12863428, 12866939, 12888444, 12922750, 12928251, 12928254, 12981358, 13015755, 13071900, 13253941, 13261457, 13261458, 13261459, 13451361, 13559353, 13654711, 13704659, 13793644, 14084357, and 14245022.  Material Catalog Number: MOO1262170 with lot numbers: 12475134, 12766168, 12813711, 12864618, 12928253, 12937147, 13052643, 13254409, 13476370, and 13605014.  Material Catalog Number: MOO1262310 with lot numbers: 12623121, 12722227, 13064473, 13254415, 13491966, 13580524, 13605081, 13797848, and 13973744.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed in Brazil, Portugal and Hong Kong.
  • Descripción del producto
    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.
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Dirección del fabricante
    Boston Scientific Corporation, 100 Boston Scientific Way, Marlborough MA 01752-1234
  • Empresa matriz del fabricante (2017)
    Boston Scientific
  • Comentario del fabricante
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    USFDA