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-0938-06
  • 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=45622
  • 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:  0000001683 0000006399 0000010421 0000012409 0000013716 0000017342 0000021394 0000021447 0000023244 0000026985 0000029266 0000029705 0000032466 0000035432 0000037924 0000042889 0000042890 0000043999 0000044001 0000044002 0000044005 0000046318 0000047374 0000051910 0000057225 0000057226 0000057227 0000058402 0000064594 0000064609 0000064622 0000064623 0000064642 0000064644 0000068966 0000068967 0000072109 0000072110 0000074335 0000074336 0000077688 0000077689 0000077723 0000077724 0000080001 0000080002 0000085367 0000088937 0000092144 0000093108 0000095216 0000099873 0000099874 0000100931 0000100932 0000102659 0000106195 0000109513 0000113247 0000118398 0000124586 0000125088 0000132238 0000133516 0000137092 0000149960 0000151195 0000170064 0000173689 0000174400 0000174416 0000175222 0000175235 0000189059 175016 178826 182733 184962 185864 188187 200447 200786 202877 203553 204960 211561 213101 214919 217583 219366 222386 222387
  • 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 3DRC W/SH LAUNC || CATHETER LA63DRCSH LA 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: LA63DRCSH
  • Manufacturer
    Medtronic, Inc.

Manufacturer

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