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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic DLP, DLP Single Stage Venous Cannulae

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 Class 2 Recall
Medtronic DLP, DLP Single Stage Venous Cannulae
see related information
Date Posted January 18, 2012
Recall Status1 Terminated on May 22, 2014
Recall Number Z-0808-2012
Recall Event ID 60720
Premarket Notification
510(K) Number
K845045 
Product Classification Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - Product Code DWF
Product Medtronic DLP, DLP Single Stage Venous Cannulae. Rx Only, Sterile EO, Nonpyrogenic. Model #'s 66112, 66114, 66116, 66118, 66120, 66122, 66124, 66126, 66128, 66130, 66132, 66134, 66236, 66238, 66240, 66136, 66140. 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 # 66112 66114 66116 66118 66120 2008110236 2008110237 2008120309 200810C094 200810C088 2008110935 2008120210 2008120640 2008110451 2008110267 2008120639 2008120908 2008120641 2008110937 2008120540 2009010197 2008121119 2008120642 2008120211 2008120643 2009010423 2009010026 2008120909 2008120746 2008120877 2009010867 2009010322 2008121003 2008120939 2009010084 2009011116 2009010868 200812C053 2008121075 2009010199 200901C051 200901C019 2009010198 200812C087 2009010324 200902C084 200901C062 2009010323 2009010887 2009011117 2009040059 2009020851 200901C070 2009011331 2009020240 2009040152 200902C070 2009020239 2009030482 2009020507 200904R099 2009040153 200902C028 2009040154 2009020635 2009051305 2009040660 200902C089 2009040662 2009040217 2009060236 2009050296 2009040973 2009040974 2009041168 200906C104 2009050640 2009041167 2009050298 2009050299 2009070459 200905C098 200904R100 2009060238 2009050985 200907R043 2009060458 2009050297 2009060238 2009060239 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2010051207 2010051208 2010051267 201005C134 2010062610 2010062697 2010062698 2010062699 2010062930 2010062931 2010070017 2010071412 2010072133 2010081502 2010082112 2010082224 2010082225 2010082226 201008C043 2010090480 2010090764 2010092263 201009C131 2010100377 2010100380 2010102075 2010102392 2010102393 2010110009 2010110012 2010110308 2010110311 2010110527 2010110528 2010110530 2010111905 2010111906 201011C136 2010121146 201012C045 2011010373 2011010374 2011011133 2011011471 201101C083 2011020604 2011020884 2011021160 2011021815 2011030054 2011031175 2011031455 2011031820 2011032525 66238 66240 2008101196 2009010877 2008110768 200907R010 2008111014 2009080161 2008111147 2009090200 200901C057 2009090679 200904R067 200909R014 2009060466 2009101092 2009060938 2010012826 200907R012 2010022237 2009080481 2010031047 2009081542 2010090067 2009081943 2010102211 2009101091 2011010123 2009101673 2011062328 2009111474 2011070232 2009112097 2011072443 200912C047 201107R040 2010012825 2010022236 2010031046 2010041079 2010062731 2010080967 2010081503 2010081688 2010101312 2010102215 2010110196 2010120637 2011051727 2011052057 201107R028 2011090265 201109C157
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 336,171
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 = DWF and Original Applicant = DLP, INC.
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