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-1846-2010
  • 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=91913
  • 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: 9814671 9815162 9821720 9821721 11019719 11039445 11040234 11061780 11061785 11065663 11065861 11126505 11164159 11164696 11172644 11172645 11209605 11209607 11460095 11463663 11489095 11489097 11501816 11550941 11564168 11595564 11614158 11659024 11668908 11668909 11713151 11717250 11744122 11748292 11752496 11791002 11791007 11808017 11821349 11828775 11828777 11887496 11908857 11966713 11966717   11986377 11987450 12000306 12070034 12070035 12084800 12084942 12112346 12112577 12122997 12122999 12144572 12144574 12158228 12158364 12201191 12202918 12235143 12235147 12237385 12251546 12251548 12257182 12338350 12339366 12342124 12350106 12376903 12419809 12460961 12462132 12511148 12545474 12548330 12589195 12625202 12635828 12656070 12673087 12678279 12695756 12778940 12884818 12912157 12971590   13003857 13022422 13064129 13074777 13114616 13117346 13133435 13194248 13194249 13200250 13222371
  • 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 - 16/40/25 Catalog Number: M00569510. 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