Events

Recall of Device Recall Cardima Surgical Ablation Probe (SAP)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cardima 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
    56046
  • Event Risk Class
    Class 2
  • Event Number
    Z-2581-2010
  • Event Initiated Date
    2010-05-20
  • Event Date Posted
    2010-09-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-03-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92513
  • 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
    Surgical device, for ablation of cardiac tissue - Product Code OCL
  • Reason
    Sterility compromised-- the sterile pouch in which the product is packaged may be compromised, which could result in patient infection.
  • Action
    Cardima issued a Product Recall Notification dated May 18, 2010 to customers, identifying the affected product, the sterility issue, and the actions to be taken by the customer. Custormers are to quarantine and return the affected product to the firm. The firm will replace returned product as soon as it becomes available. Cardima Customer Service can be contacted at 800 354-0102.

Device

Device Recall Cardima Surgical Ablation Probe (SAP)
  • Model / Serial
    Model number 01-242208
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution to Distributors in USA (Pittsburgh, PA) and the countries of Ireland and Belgium, and customers in the states of CA, OH, MI, MO, AND WA, and the countries of Ireland and the Netherlands.
  • Product Description
    Cardima Surgical Ablation Probe (SAP) Electrosurgical cutting and coagulation device, Model Number 01-242208, manufactured by Cardima Inc, Fremont, CA
  • Manufacturer
    Cardima Inc

Manufacturer

Cardima Inc
  • Manufacturer Address
    Cardima Inc, 47266 Benicia St, Fremont CA 94538-1372
  • Source
    USFDA