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-1842-2010
  • 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=91909
  • 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: 9607764 9710083 9755805 9755807 9768417 9780170 9781422 9807265 9808558 9828820 11000667 1004425 11025299 11025360 11035316 11037596 11044751 11045323 11059724 11059725 11077979 11089728 11089854 11090227 11090550 11117598 11117617 11144052 11144056 11161115 11161176 11169321 11169323 11172782 11172787 11181008 11181009 11223594 11225459 11225720 11272056 11297064 11345267 11355632 11355901   11378895 11386405 11393437 11393640 11407218 11422202 11422204 11452161 11452169 11467545 11469425 11495261 11505745 11505746 11517843 11531097 11531581 11562738 11564170 11564171 11578121 11578189 11588544 11610966 11610970 11614256 11614257 11643232 11660971 11676049 11676053 11679449 11679451 11695932 11695933 11712716 11712961 11731528 11732301 11732307 11732314 11732394 11752640 11768968 11768970   11785578 11785719 11811929 11811934 11811937 11814041 11814045 11824069 11824070 11847070 11847071 11847073 11874721 11878009 11878014 11879531 11879532 11889175 11889176 11895277 11897357 11897881 11897882 11898065 11898066 11933117 11933119 12002822 12002823 12009747 12009749 12010111 12010112 12010113 12010114 12019195 12026993 12026994 12030473 12030476 12063603 12063940 12082473 12082620 12121290   12122287 12122291 12131566 12131570 12149801 12149802 12175989 12175992 12183041 12183441 12183444 12189993 12189996 12208356 12208546 12217885 12218027 12220981 12220982 12221573 12221574 12224645 12265914 12284768 12284863 12305129 12313575 12326181 12367818 12379040 12386123 12391778 12395945 12406564 12433678 12448651 12448652 12497202 12509682 12510968 12515884 12528713 12550761 12554815 12583260   12599567 12601779 12615974 12632667 12634089 12639184 12642784 12651488 12659759 12675648 12688236 12689565 12723744 12752291 12773198 12827715 12843003 12850405 12859761 12877471 12886396 12891104 12901510 12908947 12920883 12953537 13047823 13068377 13082945 13084926 13085100 13145598 13171637 13174862 13175884 13177730 13184625 13200422 13200511 13206064 13214653 13215008
  • 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 - 12/40/25 Catalog Number: M00569450. 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