Events

Rappel de Device Recall Boston Scientific Ultraflex Tracheobronchial Distal Release 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
    73660
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1567-2016
  • Date de mise en oeuvre de l'événement
    2016-03-18
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-08-26
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144674
  • 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
    Mislabeled: 10mm diameter x 30mm length ultraflex tracheobronchial stents were labeled as 12mm diameter x 30mm.
  • Action
    Boston Scientific issued notification letters dated March 17, 2016. The notification instructs the customer to check their inventory, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests the completion of a Reply Verification Tracking Form. Customers with questions should call 866-868-4004. For questions regarding this recall call 508-382-9555.

Device

Device Recall Boston Scientific Ultraflex Tracheobronchial Distal Release Stent System
  • Modèle / numéro de série
    Lot Number: 18876596 Exp Date: February 1, 201 8
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution to AL, CA, MA, and TX.
  • Description du dispositif
    Boston Scientific Ultraflex Tracheobronchial Distal Release Stent System 12mm X 30mm || Material Number: M00576550 || The stent system is a permanently implanted expandable metal stent designed for palliation of tracheobronchial (TB) strictures. The system consists of a flexible delivery catheter preloaded with an expandable metal stent. The stent is offered in a variety of sizes of different diameters and lengths
  • 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