Events

Recall of Device Recall Edwards LifeStent FlexStar selfexpanding bilary 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
    45436
  • Event Risk Class
    Class 2
  • Event Number
    Z-0179-2008
  • Event Initiated Date
    2007-03-19
  • Event Date Posted
    2007-11-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65468
  • 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
    Bilary stent system - Product Code FGE
  • Reason
    Failure to deploy.
  • Action
    This recall was executed by an Urgent-Product Recall letter dated March 15, 2007, which was delivered via overnight service to the affected accounts on 3/19/07. In addition, the affected sales force was notified by Email and given a copy of the recall letter. The sales force was asked to assist in retrieval of the product. The letter advises that one lot of the Edwards LifeStent FlexStar Bilary Stent System -- Model EX080801CD; 8 MM x 80 MM stent, 80 CM delivery system, Lot FR6K0319 may exhibit incidences of failure to deploy and is being recalled. Customers are advised to check their inventory for lot #FR6K0319 and remove all unused product from stock. Product is to be returned or it will be retrieved. The letter also advises that if the product has been implanted, there is no need to inform the patient of this notification as this is solely related to the delivery system and the characteristics of the stent are not affected in any way. Either the customer or the sales representatives will return written notification of the status of product from this lot which had been shipped.

Device

Device Recall Edwards LifeStent FlexStar selfexpanding bilary stent system
  • Model / Serial
    Model EX080801CD; Lot FR6K0319
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide including states of OK, GA, CA WI, MO, and LA
  • Product Description
    Edwards Lifesciences LifeStent FlexStar Bilary Stent System Application, Model EX080801CD; 8 MM x 80 MM stent, 80 CM Delivery System, Lot FR6K0319, 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