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-1852-2010
  • 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=91985
  • 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: 9756366 9756988 11020192 11056395 11099754 11132479 11133187 11147078 11147156 11169806 11169807 11248614 11257090 11257098 11319126 11319246 11498702 11499093 11577525 11582509 11582515 11639672 11639674 11647173 11647422 11703446 11723976 11724210 11748608 11748610 11768753 11768755 11791250 11791251 11840263 11840266 11862820 11902118 11902460 11931828 11942286 11944801 12000422 12000425 12075443   12075444 12089895 12089896 12156911 12156953 12223030 12294304 12294305 12295796 12295798 12369548 12396685 12432385 12503377 12551946 12583949 12608681 12625461 12710132 12731246 12748492 12830620 12848174 12869065 12903982 12946195 12954565 12965789 12969280 12975407 13166713 13176564 13220243 13253488
  • 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 - 20/40/25 Catalog Number: M00569570. 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