Events

Recall of Edwards LifeStent NT Self-Expanding Stent and Delivery 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
    32030
  • Event Risk Class
    Class 2
  • Event Number
    Z-0849-05
  • Event Initiated Date
    2005-04-28
  • Event Date Posted
    2005-05-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-10-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38985
  • 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
    Stent, Coronary - Product Code MAF
  • Reason
    Potential for deployment difficulties.
  • Action
    Recall was by voice mail and regular postal service on 4/28/2005 in the USA, in Europe recall began May 2, 2005. Recall notification is complete, unused product is being returned.

Device

Edwards LifeStent NT Self-Expanding Stent and Delivery System
  • Model / Serial
    All codes.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide and Europe
  • Product Description
    Edwards LifeStent NT Self-Expanding Stent and Delivery System; || Models: NT186901(D); NT187901(D); NT186902(D); NT187902(D); NT356901(D); NT357901(D);NT356902; NT357902(D)
  • Manufacturer
    Edwards Lifesciences Llc

Manufacturer

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