Recall of Device Recall EndoVive

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Boston Scientific Corp.

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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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
    Tube, Gastro-Enterostomy - Product Code KGC
  • Reason
    Two blades may be heat staked onto the stiletto instead of the expected one blade.
  • Action
    Customers were notified by a recall letter dated 6/7/05 which instructed them to return any of the recalled products on hand.


  • Model / Serial
    Lots 7511185, 7511184, 7423558, 7421294, 7421292, 7393128, 7411790, 7411788, 7411787, 7389202, 7410534, 7410533, 7407840, 7407839, 7407838 and 7421293.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Nationwide and Panama.
  • Product Description
    Boston Scientific brand Standard PEG (percutaneous endoscopic gastrostomy tubes) Kit, 20 Fr, pull; catalog number 6820.
  • Manufacturer


  • Manufacturer Address
    Boston Scientific Corp, 780 Brookside Dr, Spencer IN 47460-1080
  • Source