Events

Recall of Device Recall Edwards LifeStent FlexStar Biliary Stent System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Edwards Lifesciences, Llc.

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
    46679
  • Event Risk Class
    Class 2
  • Event Number
    Z-1248-2008
  • Event Initiated Date
    2007-12-05
  • Event Date Posted
    2008-07-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-01-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67916
  • 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 catheter and accessories - Product Code FGE
  • Reason
    Incorrect expiration date: products were labeled with an incorrect shelf-life expiration date. therefore, the sterility of the device may be compromised.
  • Action
    Consignees were notified by an Urgent Product Recall letter sent on 12/5/07. The letter instructed users to return any affected product to the recalling firm for replacement products. The letter also advised users that the likelihood of patient complications is extremely low for products that have already been implanted in patients. Users were requested to return a confirmation form after checking the inventory for any affected products. For additional information, contact 1-949-250-3779.

Device

Device Recall Edwards LifeStent FlexStar Biliary Stent System
  • Model / Serial
    Lot Numbers: FR6G0122, (Exp 2008/07), FR6G0123 (Exp 2008/08), FR6H0193 (Exp 2008/08) and FR6H0201 (Exp 2008/08).
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution
  • Product Description
    Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX060803CD; Edwards Lifesciences LLC, Irvine, CA 92614.
  • Manufacturer
    Edwards Lifesciences, Llc

Manufacturer

Edwards Lifesciences, Llc
  • Manufacturer Address
    Edwards Lifesciences, Llc, 1 Edwards Way, Irvine CA 92614-5688
  • Source
    USFDA