{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "106300", "product_res_number": "Z-0808-2012", "event_date_initiated": "2011-12-14", "event_date_posted": "2012-01-18", "recall_status": "Terminated", "event_date_terminated": "2014-05-22", "res_event_number": "60720", "product_code": "DWF", "k_numbers": [ "K845045" ], "product_description": "Medtronic DLP, DLP Single Stage Venous Cannulae. \n\nRx Only, Sterile EO, Nonpyrogenic. Model #'s\n66112, 66114, 66116, 66118, 66120, 66122, 66124, 66126, 66128, 66130, 66132, 66134, 66236, 66238, 66240, 66136, 66140.\n\nThese 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_info": "Model # / Lot #\t\t\t\t \t\t\t\t 66112\t66114\t66116\t66118\t66120 2008110236\t2008110237\t2008120309\t200810C094\t200810C088 2008110935\t2008120210\t2008120640\t2008110451\t2008110267 2008120639\t2008120908\t2008120641\t2008110937\t2008120540 2009010197\t2008121119\t2008120642\t2008120211\t2008120643 2009010423\t2009010026\t2008120909\t2008120746\t2008120877 2009010867\t2009010322\t2008121003\t2008120939\t2009010084 2009011116\t2009010868\t200812C053\t2008121075\t2009010199 200901C051\t200901C019\t2009010198\t200812C087\t2009010324 200902C084\t200901C062\t2009010323\t2009010887\t2009011117 2009040059\t2009020851\t200901C070\t2009011331\t2009020240 2009040152\t200902C070\t2009020239\t2009030482\t2009020507 200904R099\t2009040153\t200902C028\t2009040154\t2009020635 2009051305\t2009040660\t200902C089\t2009040662\t2009040217 2009060236\t2009050296\t2009040973\t2009040974\t2009041168 200906C104\t2009050640\t2009041167\t2009050298\t2009050299 2009070459\t200905C098\t200904R100\t2009060238\t2009050985 200907R043\t2009060458\t2009050297\t2009060238\t2009060239 2009080324\t200906C130\t2009060237\t2009071380\t2009060460 200908C068\t2009071379\t2009060459\t2009080326\t2009060931 2009091604\t2009080325\t2009061232\t200909R053\t2009080410 200909R046\t2009080986\t200906C135\t2009100201\t2009080988 2009101086\t200908C079\t2009070273\t2009101666\t2009090195 2009101664\t2009091605\t200907C076\t2009111469\t2009090674 2009111468\t200909R044\t200907R022\t2009121478\t2009100202 2009112093\t2009100199\t2009080987\t2010012814\t2009102291 200911C047\t2009101665\t2009090194\t2010020253\t2009110251 2009120570\t200910C071\t200909R036\t2010022218\t200911C007 2010012811\t2009110250\t2009100200\t2010030368\t2010012815 201001C021\t2009110952\t2009101087\t2010031028\t201001C055 2010020249\t200911C046\t2009112094\t2010032267\t2010020254 2010020250\t2010012812\t2009120571\t2010040064\t2010020255 2010022215\t201001C022\t200912C163\t2010060580\t2010020256 2010051055\t2010020251\t2010012813\t2010060581\t2010022219 2010060411\t2010020252\t2010022217\t2010060694\t2010022220 2010062929\t2010022216\t2010030367\t2010062165\t2010022572 201008C042\t201003C080\t2010031027\t2010062289\t2010031029 2010091806\t2010041075\t201003C124\t2010071413\t2010031030 2010092646\t2010050804\t2010040063\t2010071499\t2010031031 2010100800\t2010050942\t2010060123\t2010090057\t2010050943 2010100867\t2010080875\t2010061485\t2010091089\t2010061610 2010101946\t2010080954\t2010061487\t2010101944\t2010061829 201011C068\t2010081634\t2010070016\t2010110954\t2010080874 2011020599\t2010090636\t201007C038\t2010110955\t2010090804 2011020600\t2010090848\t2010080609\t201011C025\t2010091506 2011021780\t2010092446\t2010090761\t2010121277\t2010101136 2011030497\t201009C076\t2010090954\t2010121278\t2010101347 201103C140\t201009C177\t2010091332\t201101C038\t2010111452 2011041594\t2010100994\t2010092652\t2011030440\t2010111731 2011050747\t2010100995\t2010100170\t2011041299\t2010111732 201106C154\t2010101778\t2010100957\t2011051721\t2011010130 2011070599\t201011C069\t2010100958\t2011052055\t201103C021 2011070600\t2011010927\t2010101779\t201106C155\t2011041300 2011070603\t2011011087\t201011C062\t2011071714\t2011041596 201107R004\t2011020336\t2011040005\t201107R006\t2011051928 201107R021\t2011020337\t2011040115\t201107R038\t2011061101 2011081471\t2011030169\t2011040115\t2011080032\t2011062713 2011090582\t2011031821\t2011040150\t2011080353\t2011070320 201110R034\t201107R015\t2011041508\t2011091496\t2011070321 \t201107R022\t2011051929\t2011092193\t2011071354 \t201110R112\t2011062012\t2011092307\t201107R023 \t\t2011070229\t2011100713\t2011080031 \t\t2011070967\t201110R115\t2011080352 \t\t2011072088\t\t2011081681 \t\t201107R005\t\t2011081769 \t\t201107R037\t\t2011082242 \t\t2011080883\t\t2011082285 \t\t2011090019\t\t201109C046 \t\t2011090556\t\t2011100453 \t\t2011091086\t\t2011100650 \t\t2011100847\t\t2011100989 \t\t201110R019\t\t201110R035 \t\t\t\t \t\t\t\t \t\t\t\t \t\t\t\t \t\t\t\t 66122\t66124\t66126\t66128\t66130 2008101158\t2008101190\t2008101373\t2008101191\t200810C062 2008110276\t2008110002\t200810C054\t2008110428\t2008110290 2008110452\t2008110006\t2008110453\t2008110716\t2008110727 2008110773\t2008110324\t200812C089\t2008110936\t2008111007 2008111005\t2008120644\t2009010029\t2008111006\t2008111008 2008120392\t2009010200\t2009010201\t2008111024\t200811C087 2008120940\t2009010870\t2009010871\t2008120213\t2008120646 2009010172\t2009011118\t2009020243\t2008120611\t2008120941 2009010325\t2009020242\t2009021161\t2008120645\t2008121002 2009010869\t2009021160\t2009030249\t2009010202\t2009011035 2009011332\t2009030248\t2009040664\t2009010326\t2009011120 200901C065\t2009031070\t2009050302\t2009010872\t2009011334 2009020241\t2009050301\t2009060462\t2009011119\t2009020244 2009020636\t2009050986\t200907R029\t2009011333\t2009021155 2009020852\t2009051337\t2009081537\t2009020832\t2009030020 2009040663\t2009060461\t200909R020\t2009020979\t2009040291 2009041169\t2009070460\t2009100204\t2009030768\t2009040667 2009050300\t2009071052\t2009111472\t2009031071\t2009040976 2009050641\t200907R038\t2009120824\t2009040218\t200904R081 2009051306\t2009080412\t2010012818\t2009040665\t2009050303 2009060240\t2009080995\t2010020261\t2009040666\t2009050643 2009060932\t2009081536\t2010022573\t2009040975\t2009050988 2009061233\t200909R034\t2010040066\t2009050642\t2009051338 2009080411\t2009100203\t2010050944\t2009050987\t2009060241 2009080989\t2009101668\t2010070858\t2009060933\t2009060463 2009080990\t200910C012\t2010081222\t2009061497\t2009060934 2009081535\t2009111471\t2010090055\t2009071053\t2009070533 2009090196\t2009121480\t2010100151\t2009071381\t2009071054 2009090675\t2010012817\t2010100993\t200907R039\t2009071382 2009091606\t2010020260\t2010101403\t2009080413\t200907R044 200909R021\t2010022223\t2010101613\t2009080991\t2009080414 2009101667\t2010022224\t201011C177\t2009090197\t2009080415 2009102292\t2010030370\t2010120024\t2009091607\t2009080992 2009110953\t2010031034\t2010120622\t200909R040\t2009081538 2009111470\t2010032944\t2011010322\t2009100205\t200908C100 2009120573\t2010040452\t2011011132\t2009101088\t2009090198 200912C149\t2010051303\t2011011938\t2009101669\t2009090676 2010012816\t2010061607\t\t2009110253\t2009090929 201001C007\t2010061907\t\t2009110254\t2009091608 2010020257\t2010071740\t\t2009110255\t200909C006 2010020258\t2010071741\t\t200911C013\t2009100206 2010020259\t2010072134\t\t200911C078\t2009100207 2010022221\t2010081641\t\t2009121481\t2009100549 2010022222\t2010092650\t\t2009121708\t2009101089 2010030369\t2010100996\t\t2010012819\t2009101670 2010031032\t2010100997\t\t201001C118\t2009102293 2010031033\t2010101947\t\t2010020262\t200910C148 2010032268\t201010C067\t\t2010022225\t2009110256 2010050405\t2010120014\t\t2010022226\t2009120574 2010051057\t2010120935\t\t2010031035\t2009120825 2010061486\t2011010928\t\t2010031036\t2009121482 2010061490\t2011011088\t\t2010032269\t200912C046 2010072132\t2011030441\t\t2010032270\t2010012820 2010080493\t2011031456\t\t2010032945\t2010020263 2010081685\t201103C141\t\t2010041512\t2010020264 2010091890\t\t\t2010051329\t2010020265 2010091891\t\t\t2010061609\t2010022227 201009C029\t\t\t2010061828\t2010030371 2010100684\t\t\t2010062608\t2010031037 2010101317\t\t\t2010062611\t2010031038 2010101318\t\t\t2010062612\t2010032271 2010101319\t\t\t2010081220\t2010032946 2010101322\t\t\t2010081501\t2010051328 2010111730\t\t\t2010082110\t2010060124 2010111998\t\t\t2010082230\t2010060582 2010111999\t\t\t2010082233\t2010060854 201011C098\t\t\t2010091090\t2010060856 2010120131\t\t\t2010091508\t2010060856 201012C044\t\t\t2010100004\t2010060856 2011010134\t\t\t2010102076\t2010061251 2011020333\t\t\t2010102077\t2010061252 2011020334\t\t\t2010102079\t2010070159 2011020338\t\t\t2010110396\t2010070568 2011020339\t\t\t2010110637\t2010070729 2011020601\t\t\t2010110641\t2010071048 2011020603\t\t\t201011C024\t2010080607 2011020954\t\t\t2010120013\t2010081687 201102C066\t\t\t2010120292\t2010090238 2011030501\t\t\t201012C082\t2010090763 201107R024\t\t\t2011010755\t2010091807 \t\t\t2011020022\t2010092137 \t\t\t2011020023\t2010100988 \t\t\t2011020951\t2010101095 \t\t\t2011021957\t2010101137 \t\t\t2011030056\t2010101479 \t\t\t2011031173\t2010101610 \t\t\t2011032149\t2010110200 \t\t\t2011032524\t2010110642 \t\t\t201103C022\t2010110645 \t\t\t\t2010111143 \t\t\t\t2010112000 \t\t\t\t2010120620 \t\t\t\t2010122185 \t\t\t\t2011010756 \t\t\t\t2011011089 \t\t\t\t2011031032 \t\t\t\t2011032523 \t\t\t\t201103C073 \t\t\t\t8*09080415 \t\t\t\t8*09080415 \t\t\t\t \t\t\t\t \t\t\t\t \t\t\t\t \t\t\t\t \t\t\t\t \t\t\t\t \t\t\t\t \t\t\t\t \t\t\t\t \t\t\t\t \t\t\t\t \t\t\t\t \t\t\t\t \t\t\t\t \t\t\t\t \t\t\t\t \t\t\t\t \t\t\t\t \t\t\t\t \t\t\t\t \t\t\t\t \t\t\t\t \t\t\t\t \t\t\t\t \t\t\t\t \t\t\t\t \t\t\t\t \t\t\t\t \t\t\t\t \t\t\t\t \t\t\t\t \t\t\t\t \t\t\t\t \t\t\t\t \t\t\t\t \t\t\t\t \t\t\t\t \t\t\t\t \t\t\t\t \t\t\t\t \t\t\t\t \t\t\t\t \t\t\t\t \t\t\t\t \t\t\t\t \t\t\t\t \t\t\t\t \t\t\t\t \t\t\t\t \t\t\t\t \t\t\t\t \t\t\t\t \t\t\t\t \t\t\t\t \t\t\t\t \t\t\t\t \t\t\t\t \t\t\t\t \t\t\t\t \t\t\t\t \t\t\t\t \t\t\t\t \t\t\t\t \t\t\t\t 66132\t66134\t66136\t66140\t66236 2008101192\t2008101194\t2009010875\t2008120649\t2008101179 2008101193\t2008110054\t200907R011\t2009010329\t2008101195 2008110093\t2008110425\t200909R058\t2009010390\t2008110325 2008110096\t2008110455\t2010100002\t2009050992\t200811C066 2008110414\t2008110725\t2010100003\t200907R013\t2008120218 2008110454\t2008111013\t2010110018\t2009090199\t2008120650 2008110748\t2008111250\t2010110395\t200909R056\t2008120773 2008111009\t2008120217\t2010121006\t2009100211\t2009010085 2008111010\t2008120648\t2010121007\t2009110954\t2009010330 2008111011\t2008120944\t2011010047\t200912C089\t2009010876 2008111012\t200812C062\t2011010328\t2010012823\t2009011122 2008120214\t2009010328\t2011020952\t2010020270\t2009030771 2008120215\t2009010874\t201102C050\t2010031043\t2009031074 2008120216\t2009011373\t2011030504\t2010041078\t2009040671 2008120647\t2009020833\t\t2010080606\t200904R070 2008120942\t2009030484\t\t2010101106\t2009050647 2008120943\t2009030770\t\t2010120623\t2009050993 2009010203\t2009031073\t\t2010121147\t2009051341 2009010327\t2009040061\t\t201110R134\t2009061235 2009010873\t2009040317\t\t\t2009071056 2009011121\t2009040670\t\t\t2009071384 2009011335\t2009041171\t\t\t200907R033 2009011336\t2009050307\t\t\t2009080480 2009020245\t2009050308\t\t\t2009081942 2009020637\t2009050646\t\t\t2009090678 2009030167\t2009050991\t\t\t2009091610 2009030181\t2009051340\t\t\t200909R043 2009030182\t2009060244\t\t\t2009100212 2009030483\t2009060465\t\t\t2009100551 2009030769\t2009060937\t\t\t2009101090 2009031072\t200907R040\t\t\t2009110262 2009040060\t2009080994\t\t\t2009110263 2009040292\t2009081540\t\t\t2010012824 2009040668\t2009081541\t\t\t2010020271 2009040669\t2009081941\t\t\t2010022234 2009040977\t2009090931\t\t\t2010022235 2009040978\t2009090932\t\t\t2010030374 2009041170\t200909R037\t\t\t2010031044 200904C011\t2009100210\t\t\t2010031045 200904R095\t2009101672\t\t\t2010032276 2009050304\t2009110261\t\t\t2010032950 2009050305\t2009112096\t\t\t201003C170 2009050306\t2009120014\t\t\t2010061605 2009050644\t200912C168\t\t\t2010062291 2009050645\t2010012822\t\t\t2010070158 2009050989\t201001C114\t\t\t2010071047 2009050990\t2010020269\t\t\t2010081684 2009051339\t2010022230\t\t\t2010081820 2009060242\t2010022231\t\t\t201009C072 2009060243\t2010022232\t\t\t2010100686 2009060464\t2010022233\t\t\t2010101382 2009060935\t2010030373\t\t\t2010101395 2009060936\t2010031042\t\t\t2010110198 2009061234\t2010032275\t\t\t2010110644 2009071055\t2010032949\t\t\t2010121562 2009071383\t2010040453\t\t\t2011012069 200907R030\t2010050406\t\t\t201101C084 2009080416\t2010050689\t\t\t2011020885 2009080417\t2010051333\t\t\t201102C069 2009080993\t2010060245\t\t\t2011041302 2009081539\t2010060246\t\t\t2011050254 2009081940\t2010070015\t\t\t2011050454 2009090677\t2010070860\t\t\t2011061103 2009090930\t2010071049\t\t\t2011062712 2009091609\t2010071498\t\t\t2011071488 2009091609\t2010090241\t\t\t2011071705 200909R032\t2010091966\t\t\t2011071706 2009100208\t2010092264\t\t\t2011071792 2009100209\t201009C145\t\t\t2011071875 2009100550\t2010102206\t\t\t201107R008 2009101671\t2010102208\t\t\t201108C070 2009110257\t2010102213\t\t\t2011090564 2009110258\t201010C032\t\t\t2011091136 2009110259\t2010110397\t\t\t2011100264 2009110260\t2010110638\t\t\t2011100534 2009111473\t2010110639\t\t\t2011101478 2009120826\t2010120291\t\t\t2011102136 2009121483\t2010120621\t\t\t201110R007 2010010283\t2010120934\t\t\t2011110012 2010012821\t2010121563\t\t\t 201001C016\t201012C097\t\t\t 201001C056\t2011021513\t\t\t 2010020266\t2011021514\t\t\t 2010020267\t2011030503\t\t\t 2010020268\t\t\t\t 2010021559\t\t\t\t 2010021560\t\t\t\t 2010021561\t\t\t\t 2010021562\t\t\t\t 2010021563\t\t\t\t 2010021564\t\t\t\t 2010021565\t\t\t\t 2010022228\t\t\t\t 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  \t \t 66238\t66240 2008101196\t2009010877 2008110768\t200907R010 2008111014\t2009080161 2008111147\t2009090200 200901C057\t2009090679 200904R067\t200909R014 2009060466\t2009101092 2009060938\t2010012826 200907R012\t2010022237 2009080481\t2010031047 2009081542\t2010090067 2009081943\t2010102211 2009101091\t2011010123 2009101673\t2011062328 2009111474\t2011070232 2009112097\t2011072443 200912C047\t201107R040 2010012825\t 2010022236\t 2010031046\t 2010041079\t 2010062731\t 2010080967\t 2010081503\t 2010081688\t 2010101312\t 2010102215\t 2010110196\t 2010120637\t 2011051727 2011052057 201107R028 2011090265 201109C157", "firm_fei_number": "2182208", "recalling_firm": "Medtronic Inc. Cardiac Rhythm Disease Management", "address_1": "8200 Coral Sea St. N.E.", "city": "Saint Paul", "state": "MN", "postal_code": "55112", "additional_info_contact": "763-526-6000", "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. \n\nMedtronic has received two reports of patient deaths due to p", "root_cause_description": "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.", "product_quantity": "336,171", "distribution_pattern": "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.", "openfda": { "k_number": [ "K180979", "K190594", "K122913", "K971023", "K032977", "K874852", "K813037", "K201100", "K241248", "K831332", "K203067", "K910021", "K791832", "K150567", "K143107", "K002857", "K253998", "K123187", "K131666", "K090533", "K905224", "K872043", "K924529", "K854640", "K964200", "K971021", "K865079", "K022174", "K932208", "K896777", "K032041", "K881074", "K961927", "K790246", "K950814", "K801359", "K111147", "K120987", "K171308", "K861496", "K993677", "K872762", "K002273", "K060101", "K791858", "K831130", "K023251", "K141951", "K801770", "K253106", "K133236", "K792202", "K930620", "K031151", "K801398", "K902394", 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