Recall of Renegade HiFlo

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
  • Event ID
  • Event Risk Class
    Class 3
  • 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
    microcatheter - Product Code KRA
  • Reason
    Outer box of the product may have an incorrect expiration date listed as 2007-06, while the correct expiration date is 2007-04.
  • Action
    Recall notification packages including a Reply Verification Tracking Form were sent to Boston Scientific representatives via Fed Ex on 8/10/2005. Boston Scientific representatives delivered the packages to the consignees. The Consignees were instructed to return affected product to Boston Scientific to be relabeled.


  • Model / Serial
    Lot Number: 7552069
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    TX, KY
  • Product Description
    Renegade Hi-Flo Microcatheter Kits, Catalog/Order # 18-299, UPN M001182990
  • Manufacturer


  • Manufacturer Address
    Boston Scientific Corporation, One Boston Scientific Place, Natick MA 01760-1536
  • Source