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-1863-2010
  • 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=92003
  • 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: 11715911 11718855 11721501 11733380 11737041 11744475 11748114 11749836 11753309 11757734 11773068 11776895 11781191 11783079 11785780 11786669 11792650 11799423 11803891 11804901 11804903 11808603 11811104 11813797 11825068 11832562 11837798 11839486 11844146 11845994 11865279 11869709 11870018 11874733 11877079 11878207 11878534 11891873 11896769 11897031 11900369 11908915 11914976 11931831 11940216 11942191 11948332 11962704 11963527 11974203 11984656 11985798 11991407 12008476 12016769 12017234 12017937 12027230 12028942 12034337 12036524 12107397 12111087 12113254 12119300 12122048 12146152 12157571 12167096 12175984 12176236 12179549 12179914 12182371 12185246 12187448 12194153 12197235 12199631 12203777 12207559 12221743 12225566 12226307 12232211 12239683 12243609 12248852 12252040 12260390 12270659 12274852 12279258 12284188 12293027 12294717 12295056 12296518 12304296 12313566 12320295 12324149 12354951 12359299 12366728 12371092 12385419 12386549 12396077 12408703 12438627 12450875 12462664 12468709 12479808 12480061 12483091 12483092 12526619 12526856 12534769 12537534 12545479 12566190 12567336 12598395 12601715 12607104 12617159 12623589 12672571 12722466 12742667 12752158 12757235 12775303 12848177 12859537 12865592 12868161 12868573 12872625 12881952 12895687 12905523 12913914 12917456 12921791 12950959
  • 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 - Distal Release - 18/23/15/12. Catalog Number M00513750. 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