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-1872-2010
  • 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=92013
  • 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: 11719777 11725283 11725285 11731295 11733159 11733871 11736240 11736245 11748221 11748222 11769533 11769534 11770660 11773069 11781831 11785979 11786181 11804308 11805464 11805927 11811114 11811115 11818475 11837788 11846979 11847061 11847062 11863089 11863095 11863828 11869296 11869297 11873760 11874291 11874294 11882312 11882313 11898225 11898226 11909787 11930243 11932623 11945700 11951637 11952126   11958154 11958155 11960385 11960393 11962429 11962483 11967085 11967545 11980803 11980814 11982653 11991875 11994430 11996651 11998952 12009046 12010821 12010822 12016310 12020766 12020767 12027558 12030201 12030205 12074060 12074063 12091024 12091025 12092122 12104701   12114475 12140967 12157547 12181371 12207523 12127208 12133084 12133089 12134191 12134193   12140325 12140857 12157549 12158887 12159025 12174459 12174542 12179559 12179762 12207527 12223707 12223708 12231513 12231515 12243095 12243096 12258817 12259636 12259638 12260762 12260769 12266966 12271481 12291496 12297083 12297086 12310288 12310290 12315146 12319215 12329858 12332564 12337624 12368066 12376074 12384123 12389243 12391993 12403515 12407131 12414945 12434427 12479810 12511711 12520902 12533381 12533534 12554981 12562315 12568674   12584795 12589918 12643281 12848192 12859858 12863307 12895028 12897936 12902732 12908445 12918858 12921793 12935498 12953825
  • 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 - Proximal Release - 23/28/10/7. Catalog Number M00514240. 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