Events

Recall of Medtronic SiteSeer 5 F Tight Radius 145 Pigtail || Cardiovascular Angiographic Catheter || Item Number: 5A0029

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic, 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
    28128
  • Event Risk Class
    Class 2
  • Event Number
    Z-0523-04
  • Event Initiated Date
    2004-01-14
  • Event Date Posted
    2004-02-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-11-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31252
  • 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
    Catheter, Intravascular, Diagnostic - Product Code DQO
  • Reason
    Catheter distal tip may separate.
  • Action
    Medtronic notified sales representatives/distributors on 1/14/04 via telephone and email and requested to retrieve affected product from the hospitals and return it to Danvers, MA. A script and effectiveness document was provided and to be reviewed with the hospital.

Device

Medtronic SiteSeer 5 F Tight Radius 145 Pigtail || Cardiovascular Angiographic Catheter || Item ...
  • Model / Serial
    Lot Number: 160760 Expiration Date: 2006-12
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    NC, WA
  • Product Description
    Medtronic SiteSeer 5 F Tight Radius 145 Pigtail || Cardiovascular Angiographic Catheter || Item Number: 5A0029
  • Manufacturer
    Medtronic, Inc.

Manufacturer

Medtronic, Inc.
  • Manufacturer Address
    Medtronic, Inc., 37a Cherry Hill Dr, Danvers MA 01923-2565
  • Source
    USFDA