Events

Recall of Medtronic

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
    35236
  • Event Risk Class
    Class 2
  • Event Number
    Z-1001-06
  • Event Initiated Date
    2006-04-05
  • Event Date Posted
    2006-06-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-06-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45830
  • 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, Percutaneous - Product Code DQY
  • Reason
    Potential for non-sterility due to loss of package integrity.
  • Action
    Medtronic notified accounts and sales representatives on 4/05/06 advising the recalled product be segregated and held for return to the sales rep. and documented on the reconciliation form.

Device

Medtronic
  • Model / Serial
    Lot Numbers: 0000055758 0000055759 0000055760 0000070849 0000071307 0000071309 0000073024 0000073025 0000075756 0000080599 0000082939 0000093035 0000096718 0000097929 0000100993 0000103729 0000110816 0000113625 0000114979 0000126421 0000130789 0000134456 0000141335 0000148442 0000149211 0000154614 0000173136 0000173875 0000175333
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Foreign: Austria, Australia, Bahrain, Bulgaria, Canada, Czech Republic, Denmark, Germany, Hungary, Italy, Jordan, France, Greece, Japan, Hong Kong, India, Italy, Norway, Poland, Portugal, Saudi Arabia, Spain, Sweden, Switzerland, UK.
  • Product Description
    CATHETER SB63DRC SB 6F 100CM 3 || CATHETER SB63DRC SB 6F 100CM 3DRC Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. || Product Code: SB63DRC
  • Manufacturer
    Medtronic, Inc.

Manufacturer

Medtronic, Inc.
  • Manufacturer Address
    Medtronic, Inc., 35 -37A Cherry Hill Dr, Danvers MA 01923-2565
  • Source
    USFDA