Events

Recall of Boston Scientific brand One Step Button (percutaneous endoscopic gastrostomy tubes) Kit, 18/4.4 pull; catalog number 6848.

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
    Recall
  • Event ID
    32383
  • Event Risk Class
    Class 2
  • Event Number
    Z-0969-05
  • Event Initiated Date
    2005-06-02
  • Event Date Posted
    2005-07-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-12-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=39960
  • 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.

Device

Boston Scientific brand One Step Button (percutaneous endoscopic gastrostomy tubes) Kit, 18/4.4 p...
  • Model / Serial
    Lot 7467697.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Panama.
  • Product Description
    Boston Scientific brand One Step Button (percutaneous endoscopic gastrostomy tubes) Kit, 18/4.4 pull; catalog number 6848.
  • Manufacturer
    Boston Scientific Corp

Manufacturer

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