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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic, Single Stage Venous Cannula

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 Class 2 Recall
Medtronic, Single Stage Venous Cannula
see related information
Date Posted January 18, 2012
Recall Status1 Terminated on May 22, 2014
Recall Number Z-0812-2012
Recall Event ID 60720
Premarket Notification
510(K) Numbers
K022272  K842375  K845045 
Product Classification Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - Product Code DWF
Product Medtronic, Single Stage Venous Cannula, Carmeda Bio-Active Surface Venous Cannula, Sterilized Using Ethylene Oxide, Rx Only, Nonpyrogenic. Model # 's CB66112, CB66114, CB66116, CB66118, CB66120, CB66122, CB66124, CB66128, CB66130, CB66132, CB66134, CB66136, CB66140, CB66236, CB66240, CB67312, CB67314, CB67316, CB67318, CB67320, CB67512, CB67514, CB67516, CB67518, CB67520, CB67522, CB67524, CB67528, CB67530, CB67532, CB67534, CB67536, CB67540, CB67636, CB67640, CB68112, CB68114, CB68116, CB68118, CB68120, CB68122, CB68124, CB68126, CB68128, CB68130, CB68132, CB68134, CB68136, CB68138, CB68140, CB69312, CB69316, CB69320,CB69322, CB69324, CB69328, CB69331, CB69428. 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 # CB66112 CB66114 CB66116 CB66118 CB66120 CB66122 11813252 11843724 11827750 11843725 11813258 11584816 11799778 11827756 11785647 11813251 11799807 11561410 11785661 11785648 11760072 11799779 11754233 11538323 11760079 11773439 11749844 11785671 11734973 11502622 11734945 11710255 11710254 11734970 11710271 11452595 11691759 11691748 11691757 11572754 11669004 11254883 11613172 11681293 11681289 11561406 11655514 11182280 11610933 11669018 11641156 11508900 11641162 11150759 11599805 11599798 11584819 11493477 11627324 11091693 11572780 11561382 11561388 11434967 11599813 10919617 11561378 11538310 11502627 11264460 11528295 10856277 11538313 11528250 11385846 11182276 11490554 10843209 11411017 11452576 11276282 11173236 11315471 10820591 11370812 11373266 11182290 11150770 11278706 10792650 11361018 11370804 11091678 11137730 11241600 10773248 11326455 11361014 11137732 11123865 11206047 10751519 11264468 11326456 11123882 11103220 11193432 10721043 11241591 11254866 11114391 11091684 11173268 10699666 11231073 11182289 11080537 11069185 11137743 10691424 11218584 11150779 11069195 11058824 11103236 10613562 11193453 11137720 11058842 11050709 11108109 10514225 11137754 11123863 11041173 11041174 11080547 10503899 11123841 11114398 11028717 11016744 11069202 10487793 11080539 11069197 10992835 10960981 11041175 10318730 11058851 11050712 10980889 10923636 10992836 10278866 11028715 11041172 10832387 10919615 10970848 10269102 11016742 11028716 10820589 10856275 10960982 10980899 11016743 10806901 10843148 10945751 10945750 11007099 10792648 10832388 10919616 10923635 10992834 10783528 10820590 10856276 10919613 10980884 10773245 10806902 10832389 10867469 10970847 10699672 10783529 10792649 10843208 10960980 10691455 10773246 10773247 10832386 10919614 10602850 10751518 10738032 10820587 10878783 10569665 10729510 10729497 10783526 10856274 10559130 10699694 10721042 10729534 10820588 10552235 10691463 10699704 10691412 10806900 10542908 10613407 10691464 10683880 10792647 10521730 10593905 10683908 10674111 10783527 10514236 10577104 10664495 10652292 10773244 10503880 10569677 10631770 10631752 10751517 10468804 10552243 10621341 10593945 10699689 10460194 10526627 10593931 10559122 10691469 10443541 10521722 10552234 10542875 10683896 10426841 10494788 10542905 10514256 10593942 10383047 10468812 10526630 10503859 10584281 10380517 10460167 10514222 10479511 10569692 10373509 10443564 10494795 10480197 10543465 10297648 10420852 10487845 10443537 10521726 10278862 10406890 10468799 10297669 10503873 10269077 10403803 10460198 10232697 10494786 10261310 10397632 10443550 10185498 10479551 10395337 10340579 10460193 10318738 10318753 10451347 10297661 10282386 10443531 10289587 10269130 10435584 10278840 10261341 10426824 10215032 10191687 10318754 10189491 10186263 10297653 10289595 10278886 10269114 10261340 10189490 CB66124 CB66128 CB66130 CB66132 CB66134 CB66136 11827767 11627333 11773446 11799799 11827744 11799792 11773419 11599767 11749845 11681291 11710269 11760052 11760049 11326472 11710245 11668999 11681284 11572757 11734956 11218598 11641155 11641159 11627296 11425915 11710265 11182291 11627304 11627300 11452588 11276285 11681302 11173246 11599769 11452587 11370813 11231093 11669022 11154396 11547341 11338577 11315466 11123840 11655492 11150767 11538311 11326447 11295324 11058807 11641165 11058804 11361023 11295323 11241607 11041178 11627311 11055669 11315461 11254872 11206081 10913654 11613167 11050669 11264444 11206086 11154378 10856281 11528290 11028718 11028719 11154399 11150748 10751522 11349220 11007101 10980910 11150747 10945753 10577107 11326462 10992837 10923637 11058847 10820595 10569700 11298131 10945752 10674167 11041177 10631766 10542971 11241610 10901167 10664513 11028720 10613551 10526622 11231080 10832391 10631746 10930780 10602851 10521720 11206066 10820593 10602783 10867470 10577109 10468760 11182272 10806904 10593927 10856280 10552240 10460162 11154406 10792651 10584280 10843149 10521701 10420850 11150755 10783531 10577075 10832392 10318761 10370321 11137740 10762628 10566526 10820594 10289594 10360543 11058849 10751521 10503905 10806905 10278841 10318727 11050668 10674164 10494797 10792652 10269112 10261331 11041176 10631765 10479479 10783532 10261334 10224560 11007100 10621311 10397558 10773250 10199614 10175944 10980906 10593951 10395345 10762629 10176023 10960984 10583515 10383009 10613400 10856278 10569669 10380509 10583513 10843210 10559114 10360542 10577110 10832390 10552204 10330246 10569667 10820592 10521705 10339016 10460147 10806903 10503888 10322855 10390319 10783530 10494753 10271119 10370317 10773249 10487834 10175986 10360551 10762627 10479514 10318749 10729512 10468767 10297689 10593914 10460140 10199613 10569680 10443571 10559134 10408590 10542901 10397633 10514237 10395341 10503891 10380514 10487802 10318809 10468761 10318755 10460163 10297693 10443563 10278837 10408593 10191685 10395325 10390317 10383058 10318747 10310127 10176022 10168504 CB66140 CB66236 CB66240 CB67312 CB67314 CB67316 11710278 10856282 10913655 11843701 11799793 11773402 10792653 11773411 11773405 11721260 11150766 10674109 11710239 11749854 11655484 10659949 11641133 11627306 11613156 11173267 11627298 11315477 11599771 11613144 11182266 11572760 11193423 11397357 11114383 11538319 11315465 11069200 11434981 11231092 11058812 11028721 11278703 11050681 11016745 11193478 11278705 11007102 11007103 11150787 10992838 10992839 11091694 11411012 10960985 10980903 11050688 10878784 10970849 11041180 11538331 10832393 10878785 10992840 10691448 10856283 10970850 11627328 10613414 10832394 10960986 10535617 10820596 10878786 11681310 10503871 10792654 10831678 10487783 10773252 10820597 10176010 10479477 10751523 10820598 10460161 10738034 10773253 10232698 10721063 10751525 10542920 10751524 10243466 10526614 10729536 10514238 10652290 10261358 10494790 10593920 10487818 10569675 10278867 10479491 10514250 10468802 10487846 10318724 10460149 10479485 10448672 10468800 10535599 10189494 10460188 10189492 10435591 10542877 10420843 10403807 10569699 10318697 10310119 10593943 10289588 10278865 10613560 10218174 10215035 10621477 10199619 10631755 10643153 10652271 10721064 10738033 10773251 11749857 CB67318 CB67320 CB67512 CB67514 CB67516 CB67518 11799773 10176018 11855547 10297643 11827753 11502624 11773388 11813261 11681280 11154374 11721247 10525864 11799808 10980872 10980877 11137718 11655500 11785633 10691420 10783533 11627302 10536236 10613365 11655464 10297644 10743959 11599778 10593901 10232496 11502625 10542894 11710275 10175992 11326452 11041181 10613552 10992841 10919618 11099826 10888953 10820599 11108114 10593939 10569674 11114403 10542917 10521697 11721238 10479539 10289593 10278876 10269127 10261354 10255194 10243449 10218173 10218172 10185494 CB67520 CB67522 CB67524 CB67528 CB67530 CB67532 11749837 11773418 11799783 11799806 11760053 11584781 11754236 11543083 11721261 11584783 11627303 11540968 11669021 11610941 11613139 11561387 11572752 11276283 11627308 11538303 11599784 11538306 11530556 11241615 11538328 11373263 11572763 11384694 11370803 11231095 11373280 11298122 11538309 11338703 11349214 11114371 11349227 11241631 11438994 11295305 11069205 11050718 11254894 11193454 11370814 11278698 11016747 11041183 11206075 11123870 11360994 11241635 10970851 11028723 11182292 11050676 11264452 11206071 10960987 11016748 11173224 10843150 11254878 11193448 10945754 10888954 11150784 10820601 11241623 11173262 10514230 10856288 11028722 10806906 11241602 11150788 10479496 10820604 11016746 10751527 11231069 11069177 10468763 10792656 11007104 10613585 11193438 11058846 10435587 10631780 10980905 10514229 11137746 11050660 10232679 10621482 10856285 10503881 11123835 10980916 10189495 10602845 10820600 10494770 11069188 10856287 10577087 10773254 10451323 11041182 10843151 10558734 10751526 10318759 10992842 10832396 10514257 10683867 10297687 10843211 10820603 10494796 10674107 10278853 10820602 10792655 10487821 10664501 10269086 10773255 10783534 10479549 10621269 10261336 10751528 10773256 10426811 10621268 10255180 10535606 10751529 10420866 10613429 10215034 10494779 10729532 10318698 10542895 10194016 10460192 10699713 10312644 10535612 10330244 10683914 10289569 10521703 10322857 10674171 10232684 10460168 10318737 10664499 10194032 10420870 10289548 10652265 10403801 10269093 10621483 10395328 10263877 10593921 10370324 10215033 10569691 10360554 10175994 10552220 10354598 10175985 10521714 10318729 10503897 10261367 10494769 10232492 10460195 10443546 10318688 10318689 10310114 10289597 10269108 10261311 10232712 10176003 CB67534 CB67536 CB67540 CB67636 CB67640 CB68112 11691780 11799776 11384688 11584779 11813262 11154393 11627325 11599804 11538291 11799809 11137721 11584818 11315473 11349219 11785634 11080525 11572761 11193472 11298129 11732169 10992843 11538318 11041185 11123878 10960988 10751531 11425919 10820606 11103223 10203287 11338574 10683900 11080542 11276288 10542972 11069189 11114390 10494789 11058850 11069187 10460144 11041186 11050717 10435537 11028724 11050654 10945756 11041184 10843212 10980901 10683865 11016749 10674110 11007105 10569684 10945755 10542973 10856289 10536238 10843152 10514216 10832397 10496084 10820605 10773257 10751530 10738035 10691438 10683882 10621494 10552233 10542876 10514241 10503889 10487832 10479499 10435543 10420860 10318732 10261372 10224561 10203282 10176011 CB68114 CB68116 CB68118 CB68120 CB68122 CB68124 11508865 11813242 11691746 11254886 11773429 11813248 11484956 11734964 11584789 11080562 11721235 11799766 11091656 11655472 11528294 11058813 11655478 11721234 11050663 11502626 11338711 11050675 11627323 11641138 11041187 11058828 11193474 11007107 11584800 11613154 10751532 11050686 11058845 10992844 11561402 11584803 10691422 11041188 11050699 10960989 11254888 11452597 10664497 11028725 11016750 10621313 11193446 11370808 10232687 10751533 11007106 10613412 11150797 11058802 10683859 10919619 10487841 11091686 11050667 10318690 10820607 10443566 10856290 11016751 10261324 10613410 10426820 10820608 10970852 10243437 10318694 10400250 10792657 10960990 10289565 10397628 10773258 10945757 10175995 10318693 10691475 10820609 10297680 10683869 10792658 10278787 10664494 10773259 10269115 10621308 10569662 10613564 10593937 10569695 10542879 10494757 10479537 10287042 CB68126 CB68128 CB68130 CB68132 CB68134 CB68136 11827739 11827760 11681282 11827757 11785639 11813223 11773407 11749829 11484942 11760046 11773435 11641135 11613138 11773410 11218603 11773447 11710259 11502597 11540970 11721254 11150750 11754238 11655466 11373272 11540971 11681294 11075680 11734949 11641125 11326445 11502612 11613145 10960991 11710244 11411011 10992845 11206082 11254859 10843153 11669002 11114370 10992845 11108136 11254874 10820611 11655473 11103232 10992845 11058827 11231072 10751535 11641126 11028726 10960993 11050687 11206077 10691449 11528261 11007110 10843214 10913656 11114372 10487840 11241589 10970853 10843214 10552215 11058811 10460171 11231067 10843213 10843214 10503882 11050674 10397562 11123833 10832399 10843214 10487839 11007108 10390340 11007109 10806908 10820612 10460143 10856291 10380510 10960992 10751536 10792659 10269111 10820610 10318733 10901168 10558730 10773260 10176024 10806907 10176012 10878787 10542980 10751537 10751534 10856293 10514226 10552239 10503895 10832398 10479478 10526617 10487799 10664505 10452170 10521715 10479543 10652262 10435573 10487833 10460133 10631764 10176013 10435575 10443547 10613578 10420853 10395326 10602844 10339017 10390320 10577111 10318721 10380506 10569697 10278857 10318723 10514228 10224558 10261342 10487801 10175977 10255183 10435535 10186264 10420856 10397560 10380515 10330247 10339020 10322860 10310107 10278881 10269080 10261309 10218186 10218176 10168507 CB68138 CB68140 CB69312 CB69316 CB69320 CB69322 11827728 11547343 No lot Manf No lot Manf 11760075 11528256 11827753 11349213 11691777 11315457 10930779 10867471 11641160 11193464 10487797 10832400 11599810 11150783 10479472 10602831 11561407 10773261 10460369 10558731 11543093 10762630 10380507 10339014 11538321 10738036 10339011 10318691 11502623 10652277 10278783 11373282 10651921 10168502 11326470 10651860 11315462 10651858 11254882 10185497 11182275 11080563 11058844 11041189 10992846 10970854 10960994 10856294 10832401 10820613 10806909 10792661 10699714 10652270 10613409 10602834 10577096 10569655 10542868 CB69324 CB69328 CB69331 CB69428 10820614 11627332 11827735 11827729 11610931 11773404 11114402 10843215 11621107 11584777 11091706 11241603 11547344 10577076 10856298 11231096 11538288 10552201 11193467 11484933 10542861 10901169 11173265 11154376 10535597 11114381 11075678 10514262 10919620 11091671 10970856 11075725 10691434 10923638 11041191 10398312 11007111 10278845 10980890 10980883 10232689 10960995 11028727 10970855 10945758 11041190 10923639 10901170 11050659 10878788 10856296 11069171 10843154 10820615 11114395 10783535 10773263 11150794 10751540 10613550 11182285 10583504 10569681 11206048 10261375 10176027 11241628 11278697 11338690 11349218 11538298 11538300 11543085 11584782 10186265 10261371 10487806 10494775 10503892 10514227 10542903 10683889 10721070 10738037 10751539 10773262 10792662 10806910
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 14,306
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.
510(K)s with Product Code = DWF and Original Applicant = MEDTRONIC CARDIAC SURGICAL PRODUCTS
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