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-1870-2010
  • 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=92010
  • 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: 11724987 11724988 11734435 11737583 11748771 11748772 11756570 11783350 11784125 11784126 11788500 11788503 11789459 11789742 11791144 11812880 11838269 11839624 11839625 11846978 11862055 11862180 11864139 11864324 11872977 11873066 11881271 11881274 11897035 11897036 11897037 11899692 11899698 11931126 11933274 11933275 11946248 11946258 11948987 11948996 11964769 11964770 11967548 11967553 11977090   11977095 11978680 11978685 11992342 11992546 12000584 12009401 12015328 12015330 12019592 12028945 12028946 12072518 12072702 12075379 12075447 12087138 12088069 12088079 12088429 12095741 12095742 12120601 12120607 12133899 12134066 12145573 12146922 12155699 12156122 12160344 12165839 12178975 12179041 12182459 12182821 12197976 12206065 12208161 12217860 12225458 12225459 12226308 12226309 12241286   12241291 12267605 12273755 12302865 12302866 12323320 12373984 12378799 12401568 12404304 12408206 12425916 12440785 12492053 12509060 12520229 12527380 12545466 12559352 12563316 12588686 12779710 12868020 12873723 12913911 12946192
  • 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 - 23/28/10/7. Catalog Number M00514200. 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