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-1855-2010
  • 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=91991
  • 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 Numbers: 9667182 9667456 9678329 976661r 9783326 9784576 11005496 11005821 11055376 11109805 11110365 11111487 11111488 11124327 11124679 11129759 11182502 11203182 11203183 11219588 11219589 11262131 11277906 11279304 11320864 11320865 11327239 11327427 11379196 11379197 11389643 11389684 11466799 11514285 11514449 11551574 11551706 11603424 11609889 11609897 11621871 11621875 11723618 11741602 11741603 11790710 11790804 11824403 11842316 11900249 11900251 11965095 11965222 12018497 12018498 12072815 12072849 12124056 12124286 12126719 I 12182401 12182408 12203718 12203719 12233126 12273963 12273964 12311839 12344667 12350349 12355457 12414762 12503049 12573392 12634334 12673096 12730542 12741518 12749444 12763036 12828633 12883686 12954041 13068696 13104060 13176719 13203739 13204940 13209979
  • 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. Uncovered - 14/40 Catalog Number: M00569920. 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