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-1871-2010
  • 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=92012
  • 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: 11717711 11724773 11724821 11740949 11740950 11758120 11773829 11773830 11776233 11781153   11823969 11783845 11824410 11784685 11785961   11825268 11841440 11787065 11845370 11789049   11845371 11789057 11859979 11812345 11860149 11823964 11870001 11872198 11872240 11879539 11879701 11909989 11909991 11926787 11928990 11939030 11940208 11942768 11942770 11944927 11944928 11948620 11948621 11964244 11969470   11975135 11975138 11976455 11976458 11978050 11980066 11981134 11981136 11987447 11987449 11991648 11992547 11992548 11993075 11999174 11999301 12012794 12012796 12015068 12015069 12018344 12018346 12020717 12020762 12028625 12028626 12070326 12070331 12086417 12088066 12092750 12092932 12101606 12104901 12108334 12108336 12114110 12141917 12144954 12144957 12148033 12148035 12161936 12167107 12167110   12175221 12175224 12200060 12200870 12202393 12202394 12204539 12215871 12225291 12256259 12270642 12270651 12310934 12312393 12317119 12320759 12336867 12353989 12358206 12378610 12394716 12396146 12412092 12445307 12466351 12495403 12499619 12534929 12549245 12550831 12579546 12583810 12607730 12757227 12759139 12851965 12867689 12877475 12884421 12887318 12901429 12912301 12930193 12950469
  • 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 - Large - Distal Release - 23/28/12/9. Catalog Number M00514210. 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