Events

Recall of Device Recall SwanGanz Thermodilution VIP Catheter

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

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
    36934
  • Event Risk Class
    Class 2
  • Event Number
    Z-0338-2007
  • Event Initiated Date
    2006-11-27
  • Event Date Posted
    2007-01-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-01-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49588
  • 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
    Thermodilution VIP Catheter - Product Code DYG
  • Reason
    Misbranding-one lot of swan-ganz thermodilution vip catheters, model 831hf75, lot 246hc197 was labeled with different model information (831f75) on the edge label . the edge label states the model is 831f75 which incorrectly indicates that product does not contain an antimicrobial heparin coating. (the tray lid label correctly states the model is 831hf75, containing the heparin coating).
  • Action
    Edwards initiated the recall in the US by sending a Customer Letter by Federal Express on November 28, 2006, along with a Q&A; to their customers Service and Direct Customers to facilitate the uderstanding of the recall and the request for verification and return of all unused product.

Device

Device Recall SwanGanz Thermodilution VIP Catheter
  • Model / Serial
    Model Number: 831FH75 Lot Number: 246HC197 Expiration Date: Feb. 2008
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution ----USA and countries of Columbia and Venezuela.
  • Product Description
    Edwards Lifesciences-Swan-Ganz,Thermodilution Venous Infusion Port (VIP) Catheter with AMC Thromboshield (An Antimicrobial*Heparin Coating), REF:831HF75
  • Manufacturer
    Edwards Lifesciences Technology SARL

Manufacturer

Edwards Lifesciences Technology SARL
  • Manufacturer Address
    Edwards Lifesciences Technology SARL, Hwy # 402 North, Km 1.4, International Industrial Park, Anasco PR 00610-1576
  • Source
    USFDA