Events

Recall of Device Recall Ultraflex Covered 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
    56331
  • Event Risk Class
    Class 2
  • Event Number
    Z-2319-2010
  • Event Initiated Date
    2010-07-15
  • Event Date Posted
    2010-08-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-10-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93245
  • 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
    Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a suture break during deployment.
  • Action
    Boston Scientific issued "Urgent Medical Device Recall - Immediate Action Required" letters dated July 15,2010 to consignees. The notification instructs the account to check their inventory, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product from their inventory. Foreign accounts received notification translated into the local language and with changes that are applicable to local regulations. Boston Scientific can be contacted at 1-508-683-4427.

Device

Device Recall Ultraflex Covered Esophageal Stent System
  • Model / Serial
    Lot/Batch Number: 13441743
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution: USA, and the countries of: Austria, Germany, Finland, France, UK, Ireland, Iran, Italy, the Netherlands, Portugual, Spain, and Sweden
  • Product Description
    Boston Scientific Ultraflex Covered Esophageal Stent System - Proximal Release (18/23/10/7) || Material/UPN/Catalog Number: M00513840
  • 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