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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 Device Recall Medtronic DLP, DLP Single Stage Venous Cannulae see related information
Date Initiated by Firm December 14, 2011
Date Posted January 18, 2012
Recall Status1 Terminated 3 on May 22, 2014
Recall Number Z-0808-2012
Recall Event ID 60720
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 2009080324 200906C130 2009060237 2009071380 2009060460 200908C068 2009071379 2009060459 2009080326 2009060931 2009091604 2009080325 2009061232 200909R053 2009080410 200909R046 2009080986 200906C135 2009100201 2009080988 2009101086 200908C079 2009070273 2009101666 2009090195 2009101664 2009091605 200907C076 2009111469 2009090674 2009111468 200909R044 200907R022 2009121478 2009100202 2009112093 2009100199 2009080987 2010012814 2009102291 200911C047 2009101665 2009090194 2010020253 2009110251 2009120570 200910C071 200909R036 2010022218 200911C007 2010012811 2009110250 2009100200 2010030368 2010012815 201001C021 2009110952 2009101087 2010031028 201001C055 2010020249 200911C046 2009112094 2010032267 2010020254 2010020250 2010012812 2009120571 2010040064 2010020255 2010022215 201001C022 200912C163 2010060580 2010020256 2010051055 2010020251 2010012813 2010060581 2010022219 2010060411 2010020252 2010022217 2010060694 2010022220 2010062929 2010022216 2010030367 2010062165 2010022572 201008C042 201003C080 2010031027 2010062289 2010031029 2010091806 2010041075 201003C124 2010071413 2010031030 2010092646 2010050804 2010040063 2010071499 2010031031 2010100800 2010050942 2010060123 2010090057 2010050943 2010100867 2010080875 2010061485 2010091089 2010061610 2010101946 2010080954 2010061487 2010101944 2010061829 201011C068 2010081634 2010070016 2010110954 2010080874 2011020599 2010090636 201007C038 2010110955 2010090804 2011020600 2010090848 2010080609 201011C025 2010091506 2011021780 2010092446 2010090761 2010121277 2010101136 2011030497 201009C076 2010090954 2010121278 2010101347 201103C140 201009C177 2010091332 201101C038 2010111452 2011041594 2010100994 2010092652 2011030440 2010111731 2011050747 2010100995 2010100170 2011041299 2010111732 201106C154 2010101778 2010100957 2011051721 2011010130 2011070599 201011C069 2010100958 2011052055 201103C021 2011070600 2011010927 2010101779 201106C155 2011041300 2011070603 2011011087 201011C062 2011071714 2011041596 201107R004 2011020336 2011040005 201107R006 2011051928 201107R021 2011020337 2011040115 201107R038 2011061101 2011081471 2011030169 2011040115 2011080032 2011062713 2011090582 2011031821 2011040150 2011080353 2011070320 201110R034 201107R015 2011041508 2011091496 2011070321  201107R022 2011051929 2011092193 2011071354  201110R112 2011062012 2011092307 201107R023  2011070229 2011100713 2011080031  2011070967 201110R115 2011080352  2011072088 2011081681  201107R005 2011081769  201107R037 2011082242  2011080883 2011082285  2011090019 201109C046  2011090556 2011100453  2011091086 2011100650  2011100847 2011100989  201110R019 201110R035           66122 66124 66126 66128 66130 2008101158 2008101190 2008101373 2008101191 200810C062 2008110276 2008110002 200810C054 2008110428 2008110290 2008110452 2008110006 2008110453 2008110716 2008110727 2008110773 2008110324 200812C089 2008110936 2008111007 2008111005 2008120644 2009010029 2008111006 2008111008 2008120392 2009010200 2009010201 2008111024 200811C087 2008120940 2009010870 2009010871 2008120213 2008120646 2009010172 2009011118 2009020243 2008120611 2008120941 2009010325 2009020242 2009021161 2008120645 2008121002 2009010869 2009021160 2009030249 2009010202 2009011035 2009011332 2009030248 2009040664 2009010326 2009011120 200901C065 2009031070 2009050302 2009010872 2009011334 2009020241 2009050301 2009060462 2009011119 2009020244 2009020636 2009050986 200907R029 2009011333 2009021155 2009020852 2009051337 2009081537 2009020832 2009030020 2009040663 2009060461 200909R020 2009020979 2009040291 2009041169 2009070460 2009100204 2009030768 2009040667 2009050300 2009071052 2009111472 2009031071 2009040976 2009050641 200907R038 2009120824 2009040218 200904R081 2009051306 2009080412 2010012818 2009040665 2009050303 2009060240 2009080995 2010020261 2009040666 2009050643 2009060932 2009081536 2010022573 2009040975 2009050988 2009061233 200909R034 2010040066 2009050642 2009051338 2009080411 2009100203 2010050944 2009050987 2009060241 2009080989 2009101668 2010070858 2009060933 2009060463 2009080990 200910C012 2010081222 2009061497 2009060934 2009081535 2009111471 2010090055 2009071053 2009070533 2009090196 2009121480 2010100151 2009071381 2009071054 2009090675 2010012817 2010100993 200907R039 2009071382 2009091606 2010020260 2010101403 2009080413 200907R044 200909R021 2010022223 2010101613 2009080991 2009080414 2009101667 2010022224 201011C177 2009090197 2009080415 2009102292 2010030370 2010120024 2009091607 2009080992 2009110953 2010031034 2010120622 200909R040 2009081538 2009111470 2010032944 2011010322 2009100205 200908C100 2009120573 2010040452 2011011132 2009101088 2009090198 200912C149 2010051303 2011011938 2009101669 2009090676 2010012816 2010061607 2009110253 2009090929 201001C007 2010061907 2009110254 2009091608 2010020257 2010071740 2009110255 200909C006 2010020258 2010071741 200911C013 2009100206 2010020259 2010072134 200911C078 2009100207 2010022221 2010081641 2009121481 2009100549 2010022222 2010092650 2009121708 2009101089 2010030369 2010100996 2010012819 2009101670 2010031032 2010100997 201001C118 2009102293 2010031033 2010101947 2010020262 200910C148 2010032268 201010C067 2010022225 2009110256 2010050405 2010120014 2010022226 2009120574 2010051057 2010120935 2010031035 2009120825 2010061486 2011010928 2010031036 2009121482 2010061490 2011011088 2010032269 200912C046 2010072132 2011030441 2010032270 2010012820 2010080493 2011031456 2010032945 2010020263 2010081685 201103C141 2010041512 2010020264 2010091890 2010051329 2010020265 2010091891 2010061609 2010022227 201009C029 2010061828 2010030371 2010100684 2010062608 2010031037 2010101317 2010062611 2010031038 2010101318 2010062612 2010032271 2010101319 2010081220 2010032946 2010101322 2010081501 2010051328 2010111730 2010082110 2010060124 2010111998 2010082230 2010060582 2010111999 2010082233 2010060854 201011C098 2010091090 2010060856 2010120131 2010091508 2010060856 201012C044 2010100004 2010060856 2011010134 2010102076 2010061251 2011020333 2010102077 2010061252 2011020334 2010102079 2010070159 2011020338 2010110396 2010070568 2011020339 2010110637 2010070729 2011020601 2010110641 2010071048 2011020603 201011C024 2010080607 2011020954 2010120013 2010081687 201102C066 2010120292 2010090238 2011030501 201012C082 2010090763 201107R024 2011010755 2010091807  2011020022 2010092137  2011020023 2010100988  2011020951 2010101095  2011021957 2010101137  2011030056 2010101479  2011031173 2010101610  2011032149 2010110200  2011032524 2010110642  201103C022 2010110645  2010111143  2010112000  2010120620  2010122185  2011010756  2011011089  2011031032  2011032523  201103C073  8*09080415  8*09080415                                                                                                                                   66132 66134 66136 66140 66236 2008101192 2008101194 2009010875 2008120649 2008101179 2008101193 2008110054 200907R011 2009010329 2008101195 2008110093 2008110425 200909R058 2009010390 2008110325 2008110096 2008110455 2010100002 2009050992 200811C066 2008110414 2008110725 2010100003 200907R013 2008120218 2008110454 2008111013 2010110018 2009090199 2008120650 2008110748 2008111250 2010110395 200909R056 2008120773 2008111009 2008120217 2010121006 2009100211 2009010085 2008111010 2008120648 2010121007 2009110954 2009010330 2008111011 2008120944 2011010047 200912C089 2009010876 2008111012 200812C062 2011010328 2010012823 2009011122 2008120214 2009010328 2011020952 2010020270 2009030771 2008120215 2009010874 201102C050 2010031043 2009031074 2008120216 2009011373 2011030504 2010041078 2009040671 2008120647 2009020833 2010080606 200904R070 2008120942 2009030484 2010101106 2009050647 2008120943 2009030770 2010120623 2009050993 2009010203 2009031073 2010121147 2009051341 2009010327 2009040061 201110R134 2009061235 2009010873 2009040317 2009071056 2009011121 2009040670 2009071384 2009011335 2009041171 200907R033 2009011336 2009050307 2009080480 2009020245 2009050308 2009081942 2009020637 2009050646 2009090678 2009030167 2009050991 2009091610 2009030181 2009051340 200909R043 2009030182 2009060244 2009100212 2009030483 2009060465 2009100551 2009030769 2009060937 2009101090 2009031072 200907R040 2009110262 2009040060 2009080994 2009110263 2009040292 2009081540 2010012824 2009040668 2009081541 2010020271 2009040669 2009081941 2010022234 2009040977 2009090931 2010022235 2009040978 2009090932 2010030374 2009041170 200909R037 2010031044 200904C011 2009100210 2010031045 200904R095 2009101672 2010032276 2009050304 2009110261 2010032950 2009050305 2009112096 201003C170 2009050306 2009120014 2010061605 2009050644 200912C168 2010062291 2009050645 2010012822 2010070158 2009050989 201001C114 2010071047 2009050990 2010020269 2010081684 2009051339 2010022230 2010081820 2009060242 2010022231 201009C072 2009060243 2010022232 2010100686 2009060464 2010022233 2010101382 2009060935 2010030373 2010101395 2009060936 2010031042 2010110198 2009061234 2010032275 2010110644 2009071055 2010032949 2010121562 2009071383 2010040453 2011012069 200907R030 2010050406 201101C084 2009080416 2010050689 2011020885 2009080417 2010051333 201102C069 2009080993 2010060245 2011041302 2009081539 2010060246 2011050254 2009081940 2010070015 2011050454 2009090677 2010070860 2011061103 2009090930 2010071049 2011062712 2009091609 2010071498 2011071488 2009091609 2010090241 2011071705 200909R032 2010091966 2011071706 2009100208 2010092264 2011071792 2009100209 201009C145 2011071875 2009100550 2010102206 201107R008 2009101671 2010102208 201108C070 2009110257 2010102213 2011090564 2009110258 201010C032 2011091136 2009110259 2010110397 2011100264 2009110260 2010110638 2011100534 2009111473 2010110639 2011101478 2009120826 2010120291 2011102136 2009121483 2010120621 201110R007 2010010283 2010120934 2011110012 2010012821 2010121563  201001C016 201012C097  201001C056 2011021513  2010020266 2011021514  2010020267 2011030503  2010020268  2010021559  2010021560  2010021561  2010021562  2010021563  2010021564  2010021565  2010022228  2010022229 2010030372 2010031039 2010031040 2010031041 2010032272 2010032273 2010032274 2010032947 2010032948 201003C120 2010040067 2010041076 2010041077 201004C057 2010050493 2010050962 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 MN 55112
For Additional Information Contact
763-526-6000
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		 Labeling design
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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DWF and Original Applicant = DLP, INC.
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