Events

Recall of Device Recall Medtronic

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

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
    25150
  • Event Risk Class
    Class 2
  • Event Number
    Z-0351-03
  • Event Initiated Date
    2002-11-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-07-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25301
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
    unknown device name - Product Code 74
  • Reason
    The radio frequency ablation pens contained unreacted epoxy resin which was observed to leak out of the back-end of the device.
  • Action
    A letter dated November 11, 2002 was sent to the affected consignees who were requested to quarantine any unused pens for retrieval by Medtronic representatives.

Device

Device Recall Medtronic
  • Model / Serial
    Lot number 2002080004
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    All of the consignees were in foreign countries in Europe, Asia and Latin America.
  • Product Description
    Medtronic Cardioblate Radio Frequency Ablation Pen, model number 60811C47
  • Manufacturer
    Medtronic Cardiac Surgery Technologies

Manufacturer

Medtronic Cardiac Surgery Technologies
  • Manufacturer Address
    Medtronic Cardiac Surgery Technologies, 7601 Northland Drive, Minneapolis MN 55428
  • Source
    USFDA