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-1850-2010
  • 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=91983
  • 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: 9680008 9681085 9700231 9700374 9713320 9713438 9734409 9802443 9803989 9817872 9818076 11028750 11028754 11058075 11089995 11105176 11105906 11108385 11108395 11135858 11178064 11178948 11189414 11204847 11326003 11326946 11346995 11346997 11408405 11408414 11411702 11411704 11423540 11428371 11441873 11441874 11491180 11491197 11524858 11525005 11535361 11535693 11555213 11555214 11582710   11582711 11633030 11641651 11641652 11663056 11663143 11666007 11666008 11681509 11681821 11735629 11757145 11758767 11789894 11790060 11803647 11803651 11807691 11807695 11830050 11859112 11859115 11862564 11862566 11871607 11873110 11873111 11911133 11929647 11931571 11950411 11994278 11994421 12017293 12032796 12071583 12071584 12085237 12085239 12095745 12155466 12179770 12182204 12182208 12200624   12236729 12248935 12252556 12252653 12303221 12303225 12318367 12323565 12355391 12356517 12360258 12392955 12403141 12440786 12504027 12521810 12565231 12591591 12620468 12634858 12657391 12658631 12678542 12723148 12746136 12756459 12834557 12844740 12852211 12868561 12871162 12899113 12981367 13004199 13035639 13061429 13065825 13072177 13077761 13108917 13118617 13177983 13180941 13188824 13190965   13196884 13281686
  • 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 - 18/60/45 Catalog Number: M00569550. 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