Events

Recall of Alsius CoolGuard 3000 Temperature Regulation System, Model CoolGuard 3000

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Alsius Corporation.

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
    29538
  • Event Risk Class
    Class 2
  • Event Number
    Z-1159-04
  • Event Initiated Date
    2004-06-21
  • Event Date Posted
    2004-07-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-12-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34038
  • 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
    System, Hypothermia, Intravenous, Cooling - Product Code NCX
  • Reason
    Higher than expected rate of pump alarms occur under specific conditions.
  • Action
    Firm replaced circuit board having a new resistor. Recall is complete.

Device

Alsius CoolGuard 3000 Temperature Regulation System, Model CoolGuard 3000
  • Model / Serial
    All codes.
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    MA, PA, VA, FL, AL, MO, TX
  • Product Description
    Alsius CoolGuard 3000 Temperature Regulation System, Model CoolGuard 3000
  • Manufacturer
    Alsius Corporation

Manufacturer

Alsius Corporation
  • Manufacturer Address
    Alsius Corporation, 15770 Laguna Canyon Rd Ste 150, Irvine CA 92618-3111
  • Source
    USFDA