Events

Recall of Device Recall Thermodilution catheter

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Abbott Laboratories HPD/ADD/GPRD.

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
    27788
  • Event Risk Class
    Class 3
  • Event Number
    Z-0305-04
  • Event Initiated Date
    2003-11-19
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-04-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30525
  • 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, Flow Directed - Product Code DYG
  • Reason
    Thermodilution catheters have a potential for ruptured lumens within the catheter.
  • Action
    Consignees were notified by letter on 11/19/2003.

Device

Device Recall Thermodilution catheter
  • Model / Serial
    List No. 41233-01, Lot 04-187-SN
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AR,AZ, CA, FL, LA, MA, NC, OR, PA, TN, TX, UT, VA, WA. VA facilities in AR,AZ,FL and NC. No military or foreign distribution.
  • Product Description
    Pentalumen TD Thermodilution Catheter, Sterile
  • Manufacturer
    Abbott Laboratories HPD/ADD/GPRD

Manufacturer

Abbott Laboratories HPD/ADD/GPRD
  • Manufacturer Address
    Abbott Laboratories HPD/ADD/GPRD, 100/200 Abbott Park Road, Abbott Park IL 60064
  • Source
    USFDA