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U.S. Department of Health and Human Services

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

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 Class 2 Recall
Medtronic, DLP, DLP Malleable Single Stage Venous Cannulae
see related information
Date Posted January 18, 2012
Recall Status1 Terminated on May 22, 2014
Recall Number Z-0810-2012
Recall Event ID 60720
Premarket Notification
510(K) Number
K022272 
Product Classification Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - Product Code DWF
Product Medtronic, DLP, DLP Malleable Single Stage Venous Cannulae. Rx Only, Sterilized Using Ethylene Oxide, Nonpyrogenic. Model #'s 68112, 68114, 68116, 68118, 68120, 68122, 68124, 68126, 68128, 68130, 68132, 68134, 68136, 68138, 68140. 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 # 68112 68114 68116 68118 68120 200810C211 2008101200 2008120907 200811C069 2008120073 2008120225 2008120308 2008121123 2008120196 2009010209 2009010348 2008120660 2009010417 2009010208 2009010850 2009010419 2008120910 2009040066 2009010349 2009011133 200902C029 2009061242 2009040685 2009011132 2009011239 2009041127 2009100221 2009041181 2009041182 2009020717 2009060944 2009110963 2009060249 2009050317 2009050710 2009071392 2010011384 200906C132 2009060486 2009060250 2009091618 2010041080 2009080496 2009081947 2009061502 2009110962 2010060595 2009080497 2009090205 2009080498 2009111482 2010060696 2009081549 2009100558 2009080999 2009120926 201008C106 200908C182 2009101686 200909R028 2009121495 2010091334 2009101104 2009120198 2009102295 2010012899 2010100685 2009120197 2010010299 2009121497 201001C063 2010101102 2009121496 201003C060 2010011385 2010050411 2010110010 2010012054 2010060923 201001C006 2010051060 2010110015 2010071304 2010070386 2010031064 2010070728 201011C075 2010080547 2010071053 2010031065 2010071051 201101C035 2010080679 2010080409 2010062293 2010081686 2011081467 2010090847 201008C148 2010091329 201008C105 2011082277 2010101777 2010092447 2010091675 201009C178 2011100126 2011041866 2010100153 2010092138 2010112026 2011051722 2010101611 2010092658 201101C036 2011070348 2010102218 2010102225 2011021958 2011090565 2010110197 2010111451 2011030171 2011090922 2010111144 2010122184 2011031823 2011100260 201011C205 2011021352 2011050659 2011052056 2011030172 2011061100 2011070537 201103C025 2011070132 2011080662 2011051728 2011080882 2011090020 2011061104 2011081468 2011091285 2011062014 201109C055 2011100261 201107R029 2011100850 2011080375 2011091486 2011092309 201109C056 2011100452 2011100851 68122 68124 68126 68128 68130 2008110235 200810C057 2008120954 200807C104 2008110978 2009010087 2008120299 2009010211 2008101176 2008120871 2009010210 200812C056 2009010351 200810C068 2009010353 2009020813 2009010350 2009011135 2008110472 2009010425 2009040656 2009010729 2009011379 2008120229 2009011448 2009040686 2009011134 2009040067 2008120559 2009020257 2009050318 200901C068 2009051346 2008120955 2009040214 2009051006 2009020712 2009061503 2008121181 2009040689 2009080500 2009030334 2009071065 2009010173 2009050320 2009081000 2009030488 2009071394 2009010352 2009060488 2009091619 2009040687 200907R014 2009010851 2009060947 2009120199 2009040982 2009080502 2009011136 2009070541 2009121498 2009041183 200909R047 2009011388 2009071067 2010070155 200904R094 2009101105 2009020256 2009071397 2010071306 2009050319 2009110964 2009030254 2009080506 2010092448 2009060945 2010010300 2009040688 2009080507 2010100105 2009071393 2010011386 2009051007 2009080508 2010111454 200907C084 2010040369 2009051347 2009081003 2011041035 2009080501 2010070156 2009060251 2009081550 2011051725 2009081001 2010070730 2009060487 2009101106 2011060723 2009100559 2010071500 2009060946 2009120929 2011061217 2009101687 2010092136 2009070540 200912C085 2011070517 2009110270 2010100375 2009071066 2010010302 2011070596 2009120200 2010101399 2009071395 2010010303 2011070597 2010012902 2010101782 2009071396 2010011388 2011070602 2010020289 2010110958 2009080503 2010011389 2011070968 2010022267 2010112027 2009080504 2010012920 201108C240 2010022268 2011010133 2009080505 2010022273 201108C241 2010060695 201101C080 2009081002 2010031070 2011090563 2010061615 2011031457 2009090206 2010032285 2011090580 2010062167 201103C239 2009090686 2010032958 2011092195 2010080387 2011041036 2009100560 2010070909 201109C215 2010091330 2011050612 2009101688 2010080957 2011100820 2010091674 2011050978 2009101689 2010081691 2011101480 2010092139 2011050979 200910C052 2010101138 2010092655 2011051407 2009120928 2010101475 2010100154 2011060722 2009121499 2010101785 2010101287 2011060783 2009121500 2010120012 2010101409 2011060943 2009121718 2010120132 2010101780 2011070970 2010012919 201012C083 201010C036 2011071095 2010022270 2011020052 201010C037 2011100259 2010022271 2011020335 2010110956 2011101779 2010022272 2011021781 2010111147 201110R045 2010030383 2011022032 201011C192 2010031066 2011031036 2011010048 2010031067 2011031822 2011010757 2010031068 2011032526 2011020882 2010031069 2011040192 2011030055 2010050494 2011050903 2011040179 2010060924 2011050975 2011041051 2010070343 2011050976 2011051406 2010070359 2011050977 2011060488 2010070596 2011061105 2011060724 2010080930 201106C131 201107C056 2010080972 2011070133 2011080376 2010090838 2011070347 2011082054 2010091331 201107C099 201108C173 2010091809 2011080659 2011090557 2010092648 201108C133 2011090584 2010101478 2011090960 2011091875 201010C038 2011091283 201109C028 2010110534 2011100535 2011100127 2010111453 2011101078 201011C086 2011101461 2010121564 2011010049 2011010493 2011011472 201101C081 2011021353 201102C151 2011031033 2011031454 2011040180 2011040190 2011040582 2011041598 2011051027 2011051027 2011051027 2011060785 2011060941 2011060942 2011070538 2011072227 201107C057 2011080639 201108C132 2011090264 2011091282 2011100987 2011102100 2011102791 68132 68134 68136 68138 68140 200808C112 2008121124 2008120663 2009030873 2009021164 2008110567 2009010028 2008120737 2009070280 2009050711 2008111025 2009010214 200812C088 2009070400 2009070619 2008120230 2009010354 2009011200 2009110968 2009071072 2008120399 2009011016 2009020933 2010080520 2009120931 2008120661 2009011390 2009021128 2010082062 2010031076 2008120662 200901C086 2009060253 2010090955 2010032288 2008121182 2009030489 2009061245 2011020953 2010070157 2009010212 2009040070 2009061504 2011030170 2010101305 2009010213 2009050056 2009071071 201103C142 2010120619 2009011389 2009050321 2009071399 2011090566 2009020662 2009060949 2009101109 2011090585 2009030783 2009061244 2009110276 2009040068 2009070279 2009110967 2009040069 2009071070 2009120213 2009041184 2009071398 2010012904 2009051008 2009080511 2010020291 2009051348 2009081551 2010022278 2009060252 2009090688 2010031075 2009060550 2009100224 2010032960 2009060948 2009101108 2010071547 2009061243 2009110275 2010100119 2009070542 2009120930 2010110957 2009071068 2009121503 2010120011 2009071069 2010010304 2011011474 200907C043 2010012923 2011021897 200907R017 2010022277 2011031013 2009080509 2010031074 2011032013 2009080510 2010032959 2011050980 2009081004 2010071046 2011060633 2009090687 2010081821 2011060899 200909R022 2010101256 2011060900 2009100222 2010101474 2011060901 2009100223 2010102203 2011062330 2009101107 2010110195 2011062331 2009101690 2010120936 2011062332 200910C141 2010122183 2011062498 2009110965 2011010046 201106C035 2009110966 2011010494 2011080975 2009121501 2011011473 201108C222 2010011390 201101C030 2011090562 2010011391 2011020054 2011090950 2010011392 2011030367 2011100817 2010012056 2011032012 2011101452 2010012921 2011032150 2011101951 2010020290 2011032151 2010022274 201103C064 2010022275 2011050626 2010022276 2011050630 2010031071 2011050631 2010031072 2011060107 2010031073 2011061424 201003C015 2011061426 2010050495 2011062015 2010050688 2011062030 2010050805 2011070228 2010062668 2011070969 2010072181 2011071094 2010072183 2011072442 2010080408 201108C221 2010080494 2011090018 2010090239 2011090074 2010091092 2011100117 2010091967 2011100643 2010100152 2011101586 2010101139 2010101140 2010110531 2010111141 2010111142 2010120636 2011010557 2011011652 2011020053 2011021161 2011031034 2011031179 2011031824 2011040181 2011040583 2011040693 2011040807 2011041481 2011050255 2011050455 2011050660 2011060634 2011060902 2011060903 2011061365 2011061421 2011061568 2011061570 2011062017 2011062127 2011062128 2011062497 2011070352 2011070397 2011071356 2011080641 2011080841 2011080843 2011081469 201108C220 2011091331 2011091514 2011092190 2011092191 2011100450 2011100819 2011101479 2011101707 2011102915 201110R046
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 139,777
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 = MEDTRONIC CARDIAC SURGICAL PRODUCTS
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