Events

Recall of Renegade

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

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
    36629
  • Event Risk Class
    Class 3
  • Event Number
    Z-0177-2007
  • Event Initiated Date
    2006-10-13
  • Event Date Posted
    2006-11-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-12-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49028
  • 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
    Catheter - Product Code KRA
  • Reason
    Incorrect expiration date: the product's exterior box date may be labeled with a longer than actual expiration date (the pouch label is correct).
  • Action
    On 10/6/06, the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be returned. Product will be destroyed upon return.

Device

Renegade
  • Model / Serial
    Lot #: 7513978
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Class III Recall-Worldwide-USA and Australia
  • Product Description
    Boston Scientific brand Renegade 18 Fiber braided microcatheter, Catalog #: 18257, UPN: M001182570
  • Manufacturer
    Boston Scientific Target

Manufacturer

Boston Scientific Target
  • Manufacturer Address
    Boston Scientific Target, 4701 Lakeview Blvd, Fremont CA 94537
  • Source
    USFDA