Events

Recall of Device Recall Ultraflex Esophageal 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-1867-2010
  • 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=92007
  • 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, esophageal - Product Code ESW
  • 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 Esophageal Stent System
  • Model / Serial
    Lot Numbers: 11716102 11718857 11721518 11729141 11730796 11734326 11737042 11740173 11742379 11747842 11748198 11748762 11751766 11752104 11754592 11756879 11758874 11770296 11776238 11776423 11776898 11781199 11783145 11784820 11786304 11786671 11788507 11793161 11800087 11800878 11801310 11802512 11807680 11808607 11810811 11814431 11818783 11819837 11820108 11820407 11822154 11822327 11827480 11829502 11838111   11839734 11841828 11845996 11846102 11846184 11846247 11846252 11846949 11859975 11861681 11861913 11863668 11877327 11877862 11880678 11883113 11891364 11893105 11896488 11900240 11914977 11925892 11927140 11928700 11929618 11929641 11931312 11943402 11944930 11947641 11958156 11958701 11959402 11959844 11961829 11962134 11963885 11965640 11966958 11968136 11975349 11977797 11984076 11984648 11987510   11995930 11999494 12007633 12009536 12019753 12019850 12020700 12030082 12031029 12031379 12033697 12034966 12067868 12072081 12075092 12080805 12086408 12088435 12089894 12094081 12094082 12110533 12110939 12112728 12114314 12122375 12131926 12133884 12140330 12143030 12145921 12148030 12149283 12160348 12168241 12185248 12187446 12198194 12202732 12205869 12216690 12220041 12220652 12221564 12223712   12224484 12224976 12225579 12235140 12235973 12253180 12253700 12256606 12267248 12271794 12274288 12274743 12276749 12284195 12284440 12293022 12295782 12297192 12304572 12310668 12314805 12320850 12323077 12329983 12330763 12336671 12336862 12340520 12341025 12342292 12347706 12350476 12356258 12360029 12366256 12373534 12386335 12389512 12397531 12406352 12419884 12432704 12438074 12438891 12439219   12447537 12448648 12459331 12464438 12468706 12490240 12490247 12500831 12503264 12508815 12508894 12512820 12512835 12516424 12520535 12530001 12534572 12547698 12548555 12552381 12553585 12567326 12568885 12577395 12642875 12643419 12645257 12654186 12678494 12686552 12690598 12722273 12723863 12780647 12827835 12844407 12846151 12847549 12849601 12853101 12855377 12860946 12862476 12864723 12866598   12868576 12880571 12884150 12884814 12887592 12888765 12895363 12896895 12899207 12900009 12902141 12906760 12912761 12918033 12920616 12921783 12929726 12932257 12932807
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - Only US distributed product is affected by recall
  • Product Description
    Ultraflex Esophageal Stent System. Covered - Proximal Release - 18/23/10/7. Catalog Number M00513840. Single Use, Rx only. Boston Scientific, Natick, MA 01760. || Intended for maintaining esophageal luminal patency in esophageal structures caused by intrinsic and/or extrinsic malignant tumors only and occlusion of concurrent esophageal fistulas.
  • 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