Events

Recall of Device Recall ABSOLUTE .035 Biliary SelfExpanding Stent System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Guidant Endovascular Solutions, Inc..

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
    35099
  • Event Risk Class
    Class 2
  • Event Number
    Z-1080-06
  • Event Initiated Date
    2006-03-22
  • Event Date Posted
    2006-06-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45321
  • 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
    Biliary Self-Expanding Stent System - Product Code FGE
  • Reason
    Design : increasing number of customer complaints with a trend of stent deployment difficulties. the difficulties are reported during acute deployment of the stent, therefore patients in whom a stent has successfully been implanted are not affected by this action.
  • Action
    Identify all customers who have been shipped affected product 2) Deliver Physician Medical Device Recall Notice and Reconciliation Form via Federal Express 3) Guidant field representatives contact hospitals by phone and in person to reinforce letter and recall plan4) Reconcile receipt notifications and physical product returns to expected returns.

Device

Device Recall ABSOLUTE .035 Biliary SelfExpanding Stent System
  • Model / Serial
    All part numbers and all lot numbers of the 135 cm length delivery catheter are affected: 1) Base Part # FG1010563; Suffix (Stent Length, mm) = -20, -30, -40, -60, -80, -100.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide
  • Product Description
    Guidant ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter), Base Part # FG1010563
  • Manufacturer
    Guidant Endovascular Solutions, Inc.

Manufacturer

Guidant Endovascular Solutions, Inc.
  • Manufacturer Address
    Guidant Endovascular Solutions, Inc., 26531 Ynez Rd, Temecula CA 92591-4630
  • Source
    USFDA