Events

Recall of Freezor cardiovascular catheter.

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

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
    36087
  • Event Risk Class
    Class 3
  • Event Number
    Z-1452-06
  • Event Initiated Date
    2006-08-04
  • Event Date Posted
    2006-08-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-01-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=47927
  • 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
    cryoablation catheter - Product Code LPB
  • Reason
    Outer cartons of catheters were mislabeled with two different reference numbers. the front of the package showed the correct reference number; 207f1, however the section on the top of the box incorrectly referenced 207f3. all inside labels (inside the box and affixed on device pouches) showed the correct reference number, 207f1.
  • Action
    Consignees were notified by letter on 08/04/2006.

Device

Freezor cardiovascular catheter.
  • Model / Serial
    Reference # 207F1, Lot number 00418.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide, including AZ, CA, CO, CT, DE, FL, GA, KY, MD, MI, NE, NY, OH, PA, TX.
  • Product Description
    7F Freezor Cardiac Cryoablation catheter, REF # 207F1. CryoCath Technologies Inc.
  • Manufacturer
    CryoCath Technologies Inc.

Manufacturer

CryoCath Technologies Inc.
  • Manufacturer Address
    CryoCath Technologies Inc., 16771 Chemin Ste-Marie, Kirkland Canada
  • Source
    USFDA