Events

Recall of Device Recall LifeStent FlexStar Stent System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bard Peripheral Vascular 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
    49405
  • Event Risk Class
    Class 2
  • Event Number
    Z-0039-2009
  • Event Initiated Date
    2008-08-29
  • Event Date Posted
    2008-10-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73537
  • 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 FGE
  • Reason
    Some lifestent flexstar systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible.
  • Action
    The customer letters for the tip to sheath gap were sent on 8/29/2008 with return receipt. The letter advises that C.R. Bard has determined that some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. Per the letter, the firm's analysis has determined that a gap between the tip of the delivery system and the delivery system sheath may be associated with difficult advancement to the treatment site. Users are instructed to inspect all devices to verify that there is not a gap between the tip and sheath (orange colored guidewire lumen is visible), prior to use and to not use any devices that exhibit a tip to sheath gap condition. If devices that exhibit a tip to sheath gap are identified, customers are advised to call Customer Service at 1-800-321-4254 to return the device and a replacement will be provided at no cost. The letter also advises that the Instructions for Use for the LifeStent FlexStar System will be updated to include the inspection step which is provided in the letter.

Device

Device Recall LifeStent FlexStar Stent System
  • Model / Serial
    Lot Numbers:58279713, 58293031, and FR6H0207,  R58270988
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide
  • Product Description
    Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060401CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
  • Manufacturer
    Bard Peripheral Vascular Inc

Manufacturer

Bard Peripheral Vascular Inc
  • Manufacturer Address
    Bard Peripheral Vascular Inc, 1625 W 3rd St, Tempe AZ 85281-2438
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA