Events

Recall of Device Recall Ultraflex tracheobronchial Stent System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Boston Scientific Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    55784
  • Event Risk Class
    Class 2
  • Event Number
    Z-1835-2010
  • Event Initiated Date
    2010-05-17
  • Event Date Posted
    2010-06-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-10-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91901
  • Notes / Alerts
    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.
  • Extra notes in the data
    Prosthesis, tracheal, expandable - Product Code JCT
  • Reason
    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
  • Model / Serial
    Lot Numbers: 9819301 11041579 11041980 11095566 11095723 11200891 11258165 11258427 11441491 11482295 11482672 11526837 11527124 11580505 11627827 11666837 11666980 11753928 11753933 11869280 11869284 11878524 11878885 11968615 11968617 12065934 12065937 12084948 12084951 12185009 12185011 12317446 12394535 12562141 12641804 12672047 12836122 12913900 13105281 13183699
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - Only US distributed product is affected by recall
  • Product Description
    Ultraflex Tracheobronchial Stent System. Uncovered - 18/60 Catalog Number: M00569270. 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
  • Manufacturer Address
    Boston Scientific Corporation, 100 Boston Scientific Way, Marlborough MA 01752-1234
  • Manufacturer Parent Company (2017)
    Boston Scientific
  • Manufacturer comment
    “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