Events

Rappel de LeVeen Standard Needle Electrode System

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Boston Scientific Corporation.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    63336
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0079-2013
  • Date de mise en oeuvre de l'événement
    2012-09-17
  • Date de publication de l'événement
    2012-10-18
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-07-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113516
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • Cause
    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.
  • 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.

Device

LeVeen Standard Needle Electrode System
  • Modèle / numéro de série
    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.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed in Brazil, Portugal and Hong Kong.
  • Description du dispositif
    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
  • Adresse du fabricant
    Boston Scientific Corporation, 100 Boston Scientific Way, Marlborough MA 01752-1234
  • Société-mère du fabricant (2017)
    Boston Scientific
  • Commentaire du fabricant
    “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