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-1826-2010
  • 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=91892
  • 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: 9703315 9714662 9714664 9821713 9821714 11037142 11037488 11065953 11067756 11085020 11107374 11107379 11119412 11120147 11187951 11187955 11329333 11330281 11356485 11356486 11393422 11393424 11458543 11459948 11506685 11506686 11541160 11541162 11578196 11578520 11597599 11597682 11610973 11610975 11678541 11678549 11696764 11696767 11753789 11753920 11787647 11787649 11821207 11883892 11883922   11888074 11888321 11895796 11895845 11907389 11907390 11963638 11964061 12033762 12033763 12101027 12101029 12113346 12113347 12140516 12140517 12150322 12150326 12217034 12217323 12225070 12225213 12251730 12251733 12284357 12312841 12329238 12334705 12377720 12409688 12414272 12426158 12552665 12571603 12620323 12643126 12654667 12707139 12739832 12746937 12778328 12831272 12831461 12851487 12868350   12897747 12933682 12975410 12989155 12992395 12992922 13074849 13149043 13167175 13171927 13204146 13218651 13220534
  • 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. Covered - 10/30/15 Catalog Number: M00569050. 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