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-0960-06
  • 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=45649
  • 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: 0000001691 0000002401 0000004678 0000006402 0000008033 0000008086 0000011110 0000011142 0000011890 0000015012 0000015797 0000017345 0000017357 0000020446 0000024950 0000029702 0000030830 0000033785 0000034253 0000036895 0000037331 0000041204 0000041290 0000043403 0000048659 0000053294 0000054630 0000056728 0000057232 0000062274 0000064619 0000065904 0000069371 0000069790 0000073906 0000075670 0000077725 0000078996 0000082350 0000082375 0000091519 0000098746 0000099570 0000099926 0000100520 0000101996 0000104796 0000106153 0000109527 0000109551 0000118394 0000120012 0000124096 0000125633 0000126524 0000130020 0000132240 0000143671 0000145703 0000151226 0000151733 0000154411 0000155713 0000159964 0000167213 0000171494 0000177092 0000178653 0000181909 0000182745 0000201295 177302 179227 180264 182327 182713 184240 187927 201562 201589 204546 205579 206975 209482 209483 213369 214129 215438 218112 220078 221415 223122 223880
  • 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
    CATH. GUIDE 6F SR4.0 LAUNCHER || CATHETER LA6SR40 LA 6F 100CM SR40 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: LA6SR40
  • Manufacturer
    Medtronic, Inc.

Manufacturer

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