Events

Recall of Device Recall Alsius Cool Line

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
    37192
  • Event Risk Class
    Class 2
  • Event Number
    Z-0503-2007
  • Event Initiated Date
    2007-01-01
  • Event Date Posted
    2007-02-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-06-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50079
  • 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
    Patient Thermal Regulation System - Product Code NCX
  • Reason
    Testing by alsius has identified that 6-10% of catheters from the three affected lots may exhibit a significant reduction in their heat exchange capacity.
  • Action
    Customer letters were sent starting January 1, 2006 via FEDEX and DHL. Verification of receipt of the notification letter to level A will be undertaken by using tracked delivery requiring signature upon receipt . The Customer letters will notify consignees of the nature of the problem and provide instructions to return the product.

Device

Device Recall Alsius Cool Line
  • Model / Serial
    Lot numbers: 16243 & 16292
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide including USA, Austria, Canada, France, Greece, Japan, Norway, Spain & Switzerland
  • Product Description
    Alsius Cool Line Catheter, Model CL-2295AE
  • Manufacturer
    Alsius Corporation

Manufacturer

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