Events

Rappel de Device Recall Boston Scientific

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
    37068
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0609-2007
  • Date de mise en oeuvre de l'événement
    2006-12-20
  • Date de publication de l'événement
    2007-03-13
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2007-12-12
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49856
  • 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
    Wallstent Endoscopic Biliary Endoprosthesis- - Product Code FGE
  • Cause
    Guidewire restriction during use (excessive adhesive in the guidewire lumen).
  • Action
    On December 20, 2006, Boston Scientific notified all US consignees by letter sent via Fed Ex Priority mail. Customers are instructed to remove affected product from inventory and return it to Boston Scientific. The notification also requested the completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product in inventory. Boston Scientific International Regulatory Affairs was notified and is responsible the monitoring foreign recall.

Device

Device Recall Boston Scientific
  • Modèle / numéro de série
    Lot Numbers: 7889257, 7892749, 7924670, 7924672, 7944542, 7948443, 7948444, 7959299, 7959300, 7975078, 7975079, 7979468, 7979469, 7991051, 7991054, 7998758, 7998759, 7998760, 8002684, 8002685, 8014025, 8041040, 8041041, 8041222, 8052772, 8052774, 8060259, 8071855, 8071856, 8075138, 8080170, 8093632, 8109650, 8109651, 8114689, 8117678, 8131078, 8151476, 8155398, 8166781, 8170747, 8174687, 8174689, 8187008, 8191493, 8206779, 8206780, 8211778, 8211779, 8214766, 8226828, 8230827, 8230830, 8231159, 8268293, 8272150, 8272151, 8284684, 8284685, 8290955, 8306944, 8319230, 8319231, 8339003, 8339005, 8343275, 8343279, 8347008, 8367859, 8367860, 8367861, 8385775, 8385776, 8385777, 8389894, 8389895, 8401051, 8406650, 8406651, 8406652, 8427648, 8427649, 8431394, 8449739, 84623248, 8466568, 8466569, 8466570, 8474529, 8474530, 8474531, 8482833, 8486629, 8486630, 8486631, 8503298, 8503299, 8503300, 8505352, 8505353, 8505354, 8505355, 8505356, 8505357, 8505358, 8505359, 8505360, 8505361, 8505362, 8505363, 8505364, 8507020, 8511088, 8526132, 8526135, 8547345, 8547346, 8551223, 8551224, 8567704, 8571917, 8571918, 8571919, 8583897, 8583898, 8583899, 8591867, 8611580, 8611581, 8614222, 8648847, 8648849, 8648850, 8655868, 8655869, 8683744, 8688103, 8692109, 8706158, 8709576, 8709923, 8709975, 8724559, 8724560, 8727932, 8727933, 8752575, 8766341, 8766342, 8775286, 8775287, 8810553, 8810554, 8810570, 8814730, 8815105, 8844670, 8844671, 8844872, 8849235, 8849236, 8849237, 8853318, 8853319, 8867181, 8893397, 8898058, 8902082, 8902083, 8913833, 8935976, 8935977, 8935978, 8948215, 8976949, 9132297, 9132373, 9132374, 9132375, 9132376, 9132377, 9132378, 9132379, 9132380, 9132381, 9132382, 9132383, 9132384, 9132385, 9132386, 9132387, 9132388, 9132389
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide distribution --- USA and countries of Austria, Belgium, France, Czech Republic, Germany, great Britain, Greece,Ireland, Italy, Luxemburg, Netherlands, Norway, Poland, Portugal, Spain, Switzerland, and Sweden.
  • Description du dispositif
    Wallstent Endoscopic Biliary Endoprosthesis 10mm x 80mm, UPN H965430600
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Adresse du fabricant
    Boston Scientific Corporation, One Boston Scientific Place, Natick MA 01760
  • Source
    USFDA