• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic CardioKit

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
 Class 2 Recall
Medtronic CardioKit
see related information
Date Posted January 18, 2012
Recall Status1 Terminated on May 22, 2014
Recall Number Z-0813-2012
Recall Event ID 60720
Premarket Notification
510(K) Number
K891687 
Product Classification Oxygenator, Cardiopulmonary Bypass - Product Code DTZ
Product Custom Packs/Mexico, Medtronic Cardio-Kit, Sterilized Using Ethylene Oxide, Nonpyrogenic, Rx Only. Model # DLP6N48R3 & DLP6N48R4. Medtronic Intersept Custom Tubing Pack with Trillium Biosurface, Sterilized Using Ethylene Oxide, , Model # TL4F71R1. These cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery up to six hours or less.
Code Information Model # / Lot # DLP6N48R3 DLP6N48R4 TL4F71R1 11241044 11465359 11799944 11755661 11713167 11713167 11669547 11616953 11568176 11509030 11478537 11432935 11414606 11282018 11252748 11239976 11209356 11130765 11110871 11101609 11051824 11015290 10916961 10860025 10816466 10693674 10656545 10588143 10502496 10454472 10426945 10310272 10255607 11669547 11616953 11568176 11509030 11478537 11432935 11414606 11282018 11252748 11239976 11209356 11130765 11110871 11101609 11051824 11015290 10916961 10860025 10816466 10693674 10656545 10588143 10502496 10454472 10426945 10310272 10255607
Recalling Firm/
Manufacturer
Medtronic Inc. Cardiac Rhythm Disease Management
8200 Coral Sea St. N.E.
Saint Paul, Minnesota 55112
Manufacturer Reason
for Recall
Instructions for Use for the DLP Single Stage Venous Cannulae are in the process of being updated. The current precaution statement referencing ventricular assist procedures will be identified as a contraindication in the updated Instructions for Use. DO NOT USE THIS PRODUCT FOR EXTENDED TERMS SUCH AS VENTRICULAR ASSIST PROCEDURES. Medtronic has received two reports of patient deaths due to p
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Labeling Change Control
Action Medtronic sent an "URGENT MEDICAL DEVICE INFORMATION" letter dated December 2011 to all affected customers. The letter identifies the product, problem, and the action to be taken by the customers. Contract Medtronic CardioVascular LifeLine Technical Support at 1-877-526-7890 for questions related to this issue.
Quantity in Commerce 106
Distribution Worldwide Distribution-USA (nationwide) including Puerto Rico and the Virgin Islands and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahamas, Bangladesh, Barbados, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macau, Macedonia, Malaysia, Mauritius, Mexico, Montenegro, Morocco, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Suriname, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Viet Nam, and Yemen.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DTZ and Original Applicant = MEDTRONIC BLOOD SYSTEMS, INC.
-
-