Events

Rappel de Device Recall Ultraflex tracheobronchial Stent 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
    55784
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1853-2010
  • Date de mise en oeuvre de l'événement
    2010-05-17
  • Date de publication de l'événement
    2010-06-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-10-20
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91986
  • 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
    Prosthesis, tracheal, expandable - Product Code JCT
  • Cause
    Suture related device failures during deployment and repositioning of the stent.
  • Action
    Boston Scientific issued an "Urgent Medical Device Recall - Immediate Action Required" notification dated May 17, 2010 to U.S. Distributors stating that use and distribution of products should cease immediately and return all affected product to the firm for replacement. Distributors were asked to complete and return reply a verification tracking form. For further information, contact Boston Scientific at 1-866-868-4004.

Device

Device Recall Ultraflex tracheobronchial Stent System
  • Modèle / numéro de série
    Lot Number: 9702666 9713744 9815286 9815735 9827448 11023940 11048031 11048060 11090552 11091623 11100787 11100789 11130407 11130409 11169593 11199527 11199535 11280856 11280880 11341089 11341176 11432241 11432242 11449851 11450165 11478740 11478748 11508004 11508006 11544543 11544548 11580979 11581280 11588652 11588654 11638613 11648449 11648451 11712580 11712582 11713706 11714530 11749295 11749401 11768151   11768153 11788880 11795319 11795584 11805726 11805727 11844354 11845372 11847118 11882868 11882870 11940557 11965234 11965643 11975795 11976130 12031087 12068298 12068464 12085102 12085111 12128423 12166213 12198180 12198183 12199117 12199299 12238417 12253760 12272254 12321133 12376164 12394715 12445215 12467922 12500371 12552399 12572753 12600206 12623799 12639192 12668979 12715336 12744279 12752674   12833389 12846410 12860388 12877943 12917360 12954186 12956938 12974683 12996101 13051719 13059606 13068104 13074855 13076093 13115832 13142196 13181128 13186398 13191494 13281348 13282288
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - Only US distributed product is affected by recall
  • Description du dispositif
    Ultraflex Tracheobronchial Stent System. Covered - 20/60/45 Catalog Number: M00569580. Single Use, Rx only. Boston Scientific, Natick, MA 01760. || Indicated for the use in the treatment of tracheobronchial structures produced by malignant neoplasms.
  • 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