Recall of Device Recall Boston Scientific 20F (6.7 mm) Standard PEG Kit

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 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
    Tubes, gastrointestinal (and accessories) - Product Code KNT
  • Reason
    The user may be unable to pass the device over the guidewire for placement in the patient, resulting in an inability to use the device.
  • Action
    Boston Scientific Corporation issued an "Urgent Medical Device Recall - Immediate Action Required" notice dated May 5, 2009 as follow-up to their "Recall of the Safety and Standard Push PEG Kits" dated December 30, 2008. The notice outlined the issue and Consignees were instructed to locate and return all affected product to the firm. In addition, the firm requests that users complete and return a Reply Verification Tracking Form via fax to 1-508-683-5578. For further questions, contact the Boston Scientific Corporation Field Action Team by phone at 1-508-683-4678.


  • Model / Serial
    UPN M00568210 and UPN M00568211 Lot Numbers: 11891623, 11906069, 11906483, 11910447, 11927475, 11927476, 11944992, 11948406, 11957306, 11969142, 11986977, 12000544, 12001423, 12025303, 12029062, 12046704, 12050348, 12061338, 12061541, 12083903, 12085669, 12110668, 12113349, 12114748, 12115371, 12130647, 12132911, 12149324, 12162040, 12162501, 12163811, 12169382, 12170033 and 12170540.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Worldwide Distribution -- United States, India, Japan and Slovenia.
  • Product Description
    Boston Scientific EndoVive 20F (6.7 mm) Standard PEG Kit, Push Method, latex free, sterile, Boston Scientific Corp., Natick, MA; Cat. no./REF 6821, inner pouch UPN M00568210 and outer carton UPN M00568211. || The devices are indicated for providing nutrition directly into the stomach in adult and pediatric patients who are unable to consume nutrition by conventional means.
  • Manufacturer


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