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-1843-2010
  • 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=91910
  • 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: 9675787 9678955 9678956 9685713 9700042 9701214 9708694 9718171 9718423 9787116 9806405 9806407 I 9825828 9825829 I 11002211 11002216 11004224 11022907 11026502 11037598 11038840 11098334 11099064 11114947 11115457 11125814 11125963 11129766 11154252 11154253 11165895 11186004 11189618 11189619 11215293 11221076 11221079 11223129 11223130 11286037 11286086 11324465 11365656 11373612 11379188 11390045 11413568 11413571 11453152 11453280 11471884 11471885 11495621 11497130 11516427 11517654 11521978 11526301 11556970 11556972 11605499 11605781 11609300 11613205 11613748 11613750 11628939 11646227 11646228 11663541 11664190 11715754 11715758 11718378 11719268 11719763 11733878 11733879 11748775 11755177 11755284 11776079 11781706 11781714 11806870 11809391 11809666 11819616 11819745 11823701 11826595 11836818 11839220 11839223 11841655 11841657 11847115 11847116 11860299 11860308 11863346 11863350 11875676 11875678 11946538 11946539 11947854 11948339 11948989 11959404 11959407 11962428 11962485 11974712 11986375 11994962 11995194 11995500 11997264 11997271 12053445 12082841 12106198 12106261 12113045 12123470 12123477 12144389 12144394 12155695 12155697 12165260 12165268 12195971 12196218 12216228 12216230 12221236 12221239 12224849 12236070 12262002 12292383 12292388 12312637 12347521 12348761 12349176 12350357 12357022 12359134 12364763 12387116 12392378 12402544 12407469 12422732 12426997 12433392 12452638 12452639 12480309 12512028 12516640 12548558 12566304 12583816 12587489 12605365 12620519 12626453 12637034 12641949 12653601 12676728 12694132 12708041 12754409 12761517 12783585 12847116 12851429 12866166 12869743 12882135 12899102 12928223 12928696 12939851 12955133 13015589 13036331 13068360 13088446 13112649 13122350 13122408 13125445 13213505 13213675 13217443 13231039
  • 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 - 14/40/25 Catalog Number: M00569480. 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