Class 2 Device Recall Ventricular Assist Device System Battery Charger

• Date Initiated by Firm: November 19, 2018
• Create Date: December 07, 2018
• Recall Status: Terminated on July 21, 2020
• Recall Number: Z-0582-2019
• Recall Event ID: 81609
• PMA Number: P100047
• Product Classification: Ventricular (assist) bypass - Product Code DSQ
• Product: Medtronic HeartWare Ventricular Assist HVAD System Battery Charger Model 1600US - Product Usage: The HeartWare Ventricular Assist System (HVAD) is indicated in the United States (US) and European Union (EU) for use as a bridge to cardiac transplantation (BTT) as well as an alternative to transplantation as destination therapy (DT) for patients who are at risk of death from refractory end-stage left ventricular heart failure. The HVAD Pump Controller is a microprocessor unit that controls and manages HeartWare System operation. It sends power and operating signals to the blood pump and collects information from the pump. The controller requires two power sources for safe operation: either two batteries, or one battery and an AC adapter or DC adapter. While active, patients will typically use two batteries. While relaxing or sleeping, patients should use power from an electrical outlet (AC adapter) because it provides power for an unlimited period of time. The HeartWare Battery Charger is part of the HeartWare Ventricular Assist System (HVAD). Patients receive 4 total batteries with their system along with a battery charger and are instructed to have spare, fully charged batteries always available. The battery charger can charge up to 4 batteries at a time using 4 charging bays. Each battery slides into a bay and is connected to the battery charger.
• Code Information: BCH000403, BCH000405, BCH000406, BCH000415, BCH000420, BCH000422, BCH000423, BCH000426, BCH000428, BCH000433, BCH000435, BCH000440, BCH000442, BCH000446, BCH000451, BCH000456, BCH000459, BCH000464, BCH000465, BCH000470, BCH000471, BCH000472, BCH000475, BCH000484, BCH000485, BCH000486, BCH000490, BCH000493, BCH000495, BCH000500, BCH000502, BCH000503, BCH000507, BCH000514, BCH000523, BCH000524, BCH000525, BCH000526, BCH000527, BCH000528, BCH000530, BCH000531, BCH000534, BCH000537, BCH000543, BCH000553, BCH000554, BCH000556, BCH000564, BCH000565, BCH000567, BCH000570, BCH000573, BCH000574, BCH000575, BCH000576, BCH000577, BCH000579, BCH000580, BCH000583, BCH000586, BCH000590, BCH000592, BCH000593, BCH000594, BCH000595, BCH000598, BCH000601, BCH000602, BCH000603, BCH000607, BCH000610, BCH000612, BCH000616, BCH000628, BCH000631, BCH000633, BCH000635, BCH000637, BCH000640, BCH000644, BCH000645, BCH000653, BCH000654, BCH000656, BCH000657, BCH000658, BCH000659, BCH000660, BCH000666, BCH000667, BCH000668, BCH000670, BCH000671, BCH000675, BCH000676, BCH000677, BCH000680, BCH000688, BCH000690, BCH000691, BCH000693, BCH000694, BCH000695, BCH000696, BCH000697, BCH000698, BCH000702, BCH000703, BCH000706, BCH000713, BCH000715, BCH000716, BCH000721, BCH000722, BCH000728, BCH000733, BCH000734, BCH000735, BCH000739, BCH000740, BCH000743, BCH000745, BCH000748, BCH000750, BCH000757, BCH000758, BCH000760, BCH000761, BCH000762, BCH000763, BCH000764, BCH000767, BCH000769, BCH000771, BCH000772, BCH000776, BCH000783, BCH000869, BCH000870, BCH000872, BCH000873, BCH000876, BCH000877, BCH000881, BCH000885, BCH000887, BCH000888, BCH000890, BCH000894, BCH000895, BCH000902, BCH000906, BCH000914, BCH000915, BCH000921, BCH000924, BCH000925, BCH000926, BCH000930, BCH000931, BCH000938, BCH000941, BCH000945, BCH000946, BCH000947, BCH000948, BCH000949, BCH000950, BCH000953, BCH000954, BCH000959, BCH000964, BCH000966, BCH000967, BCH000976, BCH000977, BCH000979, BCH000985, BCH000987, BCH000989, BCH000991, BCH000993, BCH000994, BCH000995, BCH001004, BCH001005, BCH001007, BCH001009, BCH001010, BCH001011, BCH001015, BCH001016, BCH001025, BCH001035, BCH001036, BCH001040, BCH001042, BCH001043, BCH001044, BCH001045, BCH001047, BCH001049, BCH001056, BCH001063, BCH001065, BCH001072, BCH001086, BCH001091, BCH001103, BCH001109, BCH001110, BCH001111, BCH001112, BCH001114, BCH001117, BCH001118, BCH001119, BCH001121, BCH001129, BCH001134, BCH001136, BCH001142, BCH001152, BCH096768, BCH096770, BCH096771, BCH096773, BCH096775, BCH096779, BCH096782, BCH096785, BCH096787, BCH096789, BCH096790, BCH096791, BCH096794, BCH096796, BCH096799, BCH096800, BCH096801, BCH096804, BCH096805, BCH096806, BCH096811, BCH096812, BCH096813, BCH096818, BCH096820, BCH096821, BCH096822, BCH096827, BCH096828, BCH096830, BCH096832, BCH096833, BCH096836, BCH096850, BCH096924, BCH096936, BCH096947, BCH096954, BCH096956, BCH096959, BCH096962, BCH096963, BCH096964, BCH096967, BCH096968, BCH096969, BCH096972, BCH096973, BCH096974, BCH096975, BCH096976, BCH096977, BCH096978, BCH096979, BCH096981, BCH096983, BCH096984, BCH096985, BCH096986, BCH096987, BCH096989, BCH096990, BCH096992, BCH096993, BCH096994, BCH096996, BCH096997, BCH096998, BCH096999, BCH097001, BCH097003, BCH097004, BCH097005, BCH097006, BCH097007, BCH097010, BCH097012, BCH097013, BCH097014, BCH097015, BCH097016, BCH097017, BCH097020, BCH097021, BCH097022, BCH097051, BCH097052, BCH097053, BCH097054, BCH097055, BCH097056, BCH097060, BCH097061, BCH097066, BCH097067, BCH097068, BCH097069, BCH097070, BCH097075, BCH097076, BCH097078, BCH097079, BCH097083, BCH097088, BCH097091, BCH097092, BCH097094, BCH097096, BCH097098, BCH097100, BCH097101, BCH097103, BCH097104, BCH097107, BCH097110, BCH097112, BCH097113, BCH097114, BCH097117, BCH097120, BCH097122, BCH097123, BCH097125, BCH097129, BCH097131, BCH097132, BCH097134, BCH097135, BCH097137, BCH097199, BCH097201, BCH097202, BCH097206, BCH097208, BCH097209, BCH097210, BCH097211, BCH097212, BCH097213, BCH097214, BCH097215, BCH097217, BCH097218, BCH097219, BCH097222, BCH097224, BCH097225, BCH097226, BCH097227, BCH097228, BCH097230, BCH097232, BCH097233, BCH097235, BCH097236, BCH097237, BCH097238, BCH097240, BCH097241, BCH097243, BCH097244, BCH097245, BCH097246, BCH097249, BCH097250, BCH097254, BCH097255, BCH097257, BCH097259, BCH097260, BCH097263, BCH097264, BCH097265, BCH097269, BCH097272, BCH097273, BCH097275, BCH097279, BCH097312, BCH097328, BCH097359, BCH097363, BCH097370, BCH097374, BCH097375, BCH097382, BCH097383, BCH097385, BCH097387, BCH097388, BCH097392, BCH097395, BCH097397, BCH097398, BCH097400, BCH097404, BCH097405, BCH097406, BCH097407, BCH097408, BCH097409, BCH097411, BCH097418, BCH097419, BCH097420, BCH097425, BCH097426, BCH097428, BCH097429, BCH097430, BCH097431, bch097432, BCH097433, BCH097434, BCH097437, BCH097438, BCH097439, bch097440, BCH097441, BCH097443, bch097446, bch097447, bch097448, bch097449, bch097450, bch097451, bch097452, bch097453, BCH097454, bch097458, BCH097460, BCH097461, BCH097462, BCH097464, BCH097466, bch097467, bch097468, bch097470, BCH097472, BCH097473, BCH097474, BCH097475, BCH097477, BCH097478, BCH097480, BCH097482, BCH097484, BCH097485, BCH097488, BCH097489, BCH097490, BCH097491, BCH097492, BCH097495, BCH097496, BCH097497, bch097498 BCH097499 BCH097506 BCH097507 bch097509 BCH097511 BCH097516 BCH097519 BCH097520 bch097524 BCH097525 BCH097526 BCH097528 BCH097529 BCH097530 BCH097534 BCH097538 BCH097545 BCH097548 BCH097560 BCH097568 BCH097569 BCH097578 BCH097582 BCH097586 BCH097587 BCH097588 BCH097591 BCH097593 BCH097595 BCH097596 BCH097607 BCH097610 BCH097611 BCH097617 BCH097621 BCH097623 BCH097624 BCH097625 BCH097627 BCH097628 BCH097629 BCH097630 BCH097631 BCH097633 BCH097634 BCH097635 BCH097636 BCH097638 BCH097639 BCH097640 BCH097643 BCH097644 BCH097645 BCH097646 BCH097647 BCH097649 BCH097650 BCH097651 BCH097652 BCH097655 BCH097656 BCH097657 BCH097658 BCH097659 BCH097660 BCH097661 BCH097663 BCH097665 BCH097666 BCH097667 BCH097668 BCH097669 BCH097671 BCH097672 BCH097673 BCH097674 BCH097675 BCH097677 BCH097678 BCH097679 BCH097680 BCH097682 BCH097683 BCH097696 BCH097707 BCH097708 BCH097728 BCH097738 BCH097748 BCH097749 BCH097751 BCH097752 BCH097762 BCH097763 BCH097770 BCH097782 BCH097787 BCH097790 BCH097791 BCH097806 BCH097817 bch097828 bch097830 bch097831 BCH097832 bch097840 bch097841 BCH097843 bch097844 bch097846 bch097848 bch097850 bch097855 bch097856 BCH097857 BCH097858 bch097861 BCH097868 BCH097869 BCH097870 BCH097871 BCH097872 BCH097873 BCH097874 BCH097875 BCH097876 BCH097877 BCH097878 BCH097881 BCH097883 BCH097885 BCH097886 BCH097888 bch097889 BCH097890 BCH097891 BCH097893 BCH097897 BCH097900 BCH097901 BCH097903 BCH097904 BCH097905 BCH097906 BCH097909 BCH097910 BCH097912 BCH097913 BCH097916 BCH097918 BCH097923 BCH097930 BCH097931 BCH097934 BCH097935 BCH097938 BCH097946 BCH097948 BCH097949 BCH097950 BCH097951 BCH097954 bch097958 BCH097959 BCH097960 BCH097961 BCH097962 BCH097963 BCH097964 BCH097965 BCH097967 BCH097973 BCH097974 BCH097981 BCH097991 BCH097992 BCH098014 BCH098025 BCH098060 BCH098061 BCH098062 bch098072 bch098073 BCH098075 BCH098076 BCH098077 BCH098078 BCH098079 BCH098080 bch098081 BCH098083 BCH098084 BCH098088 BCH098091 bch098095 BCH098097 BCH098100 bch098103 BCH098104 bch098105 BCH098106 BCH098107 bch098108 BCH098111 BCH098113 BCH098114 bch098115 bch098116 bch098119 bch098120 BCH098122 bch098123 bch098124 bch098125 bch098127 bch098128 bch098129 BCH098139 BCH098142 BCH098144 BCH098145 BCH098146 BCH098155 BCH098157 BCH098158 BCH098165 BCH098166 BCH098173 BCH098175 BCH098179 BCH098184 BCH098229 BCH098230 BCH098234 BCH098249 BCH098256 BCH098259 BCH098262 BCH098263 BCH098264 BCH098265 BCH098268 BCH098269 BCH098270 BCH098271 BCH098272 BCH098273 BCH098274 BCH098275 BCH098276 BCH098278 BCH098279 BCH098280 BCH098281 BCH098282 BCH098283 BCH098284 BCH098285 BCH098286 BCH098288 BCH098289 BCH098290 BCH098292 BCH098293 BCH098294 BCH098295 BCH098296 BCH098298 BCH098299 BCH098301 BCH098304 BCH098305 BCH098306 BCH098307 BCH098308 BCH098309 BCH098310 BCH098311 BCH098312 BCH098316 BCH098353 BCH098375 BCH098389 BCH098396 BCH098411 BCH098412 BCH098414 BCH098415 BCH098416 BCH098417 BCH098421 BCH098425 BCH098426 BCH098427 BCH098428 BCH098430 BCH098431 BCH098432 BCH098433 BCH098434 BCH098435 BCH098436 BCH098437 BCH098438 BCH098439 BCH098440 BCH098441 BCH098442 BCH098443 BCH098444 BCH098445 BCH098446 BCH098447 BCH098448 BCH098449 BCH098450 BCH098451 BCH098453 BCH098454 BCH098455 BCH098456 BCH098457 BCH098458 BCH098459 BCH098460 BCH098461 BCH098467 BCH098488 BCH098502 BCH098516 BCH098561 BCH098562 BCH098563 BCH098568 BCH098574 BCH098575 BCH098577 BCH098579 BCH098580 BCH098581 BCH098582 BCH098583 BCH098585 BCH098588 BCH098589 BCH098590 BCH098591 BCH098592 BCH098593 BCH098594 BCH098595 BCH098596 BCH098598 BCH098599 BCH098600 BCH098601 BCH098602 BCH098603 BCH098604 BCH098605 BCH098606 BCH098607 BCH098608 BCH098609 BCH098610 BCH098612 BCH098613 BCH098614 BCH098615 BCH098616 BCH098619 BCH098620 BCH098621 BCH098622 BCH098623 BCH098624 BCH098625 BCH098626 BCH098628 BCH098630 BCH098648 BCH098669 BCH098700 BCH098702 BCH098712 BCH098746 BCH098757 BCH098760 BCH098787 BCH098822 BCH098826 BCH098833 BCH098835 BCH098885 BCH098968 BCH098998 BCH098999 BCH001098 BCH000916 BCH001094 BCH000407 BCH000469 BCH000704 BCH001014 BCH001033 BCH001037 BCH000496 BCH000912 BCH001093 BCH000875 BCH000497 BCH000971 BCH000547 BCH000450 BCH000498 BCH000452 BCH000904 BCH000455 BCH000539 BCH001026 BCH000898 BCH000448 BCH000982 bch000683 BCH000973 BCH001147 BCH001082 BCH000439 BCH000544 BCH000669 BCH000974 bch000917 BCH000981 BCH001099 BCH001102 BCH000558 BCH000615 BCH000727 BCH000585 BCH000506 BCH000903 BCH000546 BCH000996 BCH000951 BCH000401 BCH000515 BCH000404 BCH001140 BCH001021 BCH001107 BCH000591 BCH000563 BCH001031 BCH000557 BCH098834 BCH000899 BCH000538 BCH000512 BCH001120 BCH001019 BCH001022 BCH000430 BCH001073 BCH000880 BCH000611 BCH000741 BCH000775 BCH000545 BCH001163 BCH001160 BCH000562 BCH000935 BCH000778 BCH001002 BCH000850 BCH000882 BCH000883 BCH001116 BCH000751 BCH000848 BCH000897 BCH000864 BCH001039 BCH000922 BCH000505 BCH000952 BCH000536 BCH001055 BCH000701 BCH000777 BCH000955 BCH000779 BCH000969 BCH000961 BCH001071 BCH000962 BCH000963 BCH000980 BCH000532 BCH000997 BCH000516 BCH000998 BCH000720 BCH001001 BCH000988 BCH001053 BCH000965 BCH000714 BCH000416 bch000742 BCH000724 BCH000936 BCH000896 BCH000766 BCH001146 BCH000684 BCH000908 BCH000891 BCH000482 BCH000481 bch000884 BCH000893 BCH000752 BCH000911 BCH000413 BCH000453 BCH000582 BCH000651 BCH000744 BCH000754 BCH000454 BCH000920 BCH000990 BCH001079 BCH000468 BCH000905 BCH000441 BCH001032 BCH000402 BCH000449 BCH000488 BCH000958 BCH000489 BCH096866 BCH000467 BCH000491 BCH001006 BCH000655 BCH001097 BCH001061 BCH000968 BCH001038 BCH000566 BCH000542 bch000918 BCH000473 BCH000597 BCH000517 BCH000584 BCH001076 BCH000596 BCH000940 BCH000943 BCH000460 BCH000956 BCH000672 BCH000957 BCH001127 BCH000443 BCH000738 BCH001100 BCH000561 BCH000755 BCH001106 BCH000541 BCH000520 bch000707 BCH000521 BCH001059 BCH001067 BCH000939 BCH000599 BCH000509 BCH000510 bch000774 BCH000878 BCH001069 BCH001060 BCH001145 BCH000642 BCH000909 BCH000555 BCH000552 BCH001078 BCH000913 BCH000986 BCH001077 BCH000901 BCH001068 BCH001070 BCH000535 BCH001075 BCH000589 BCH000606 BCH000540 BCH000629 BCH000975 BCH001041 BCH000569 BCH001153 BCH000708 BCH001080 BCH001113 BCH000447 BCH001096 BCH001108 BCH000550 BCH096856 BCH096858 BCH096862 BCH096865 bch097368 BCH096870 BCH096871 BCH096876 BCH096877 BCH096878 BCH096879 BCH096880 BCH096881 BCH096882 BCH096886 BCH096887 BCH096890 BCH096892 BCH096893 BCH097664 BCH096899 BCH096900 BCH096902 BCH096904 BCH096907 BCH096911 BCH096912 BCH096914 BCH096916 BCH098022 BCH096772 BCH096929 BCH096803 BCH096807 BCH096860 BCH097705 BCH097505 BCH097024 BCH097025 BCH097029 BCH097030 BCH097033 BCH097035 BCH097036 BCH097170 BCH097037 BCH097038 BCH097040 BCH097041 BCH097042 BCH097044 BCH097045 BCH097046 BCH097047 BCH097050 BCH097057 BCH097058 BCH097059 BCH097062 BCH097063 BCH097064 BCH097065 BCH097071 BCH097072 BCH097073 BCH097074 BCH097077 BCH097080 BCH097081 BCH097082 BCH097084 BCH097085 BCH097086 BCH097087 BCH097089 BCH097090 BCH097093 BCH098036 BCH097095 BCH097097 BCH097099 BCH097102 BCH097105 BCH097106 BCH097108 BCH097140 BCH097141 BCH097144 BCH097150 BCH097152 BCH097154 BCH097156 BCH097157 BCH097158 BCH097159 BCH097160 BCH097161 BCH097164 BCH097169 BCH097517 BCH097174 BCH097176 BCH097180 BCH097181 BCH097767 BCH097184 BCH097986 BCH097189 BCH097191 BCH097194 BCH097196 BCH097200 BCH097203 BCH097204 BCH097205 BCH098048 BCH097216 BCH097220 BCH097221 BCH097223 BCH097229 BCH097231 BCH097688 BCH097234 BCH097242 BCH097247 BCH097248 BCH097251 BCH097253 BCH097282 BCH097285 BCH097286 BCH097287 BCH001081 BCH097288 BCH097289 BCH097290 BCH097292 BCH097735 BCH097295 BCH097297 BCH097299 BCH097301 BCH097302 BCH097303 BCH097304 BCH097305 BCH097307 BCH097308 BCH097309 BCH097311 BCH097536 BCH097322 BCH097335 BCH097342 BCH097343 BCH097346 BCH097349 BCH097351 BCH097355 BCH097356 BCH097357 BCH097361 BCH097364 BCH097366 BCH097369 BCH097371 BCH097372 BCH097373 BCH097379 BCH097381 BCH097384 BCH097386 BCH097389 BCH097390 BCH097391 BCH097393 BCH097394 BCH096867 BCH096769 BCH098054 BCH097797 BCH097603 BCH097626 BCH097632 BCH097637 BCH097641 BCH097642 BCH097653 BCH097654 BCH096897 BCH097670 BCH097291 BCH097535 BCH097547 BCH097692 BCH097693 BCH097694 BCH097695 BCH097781 BCH097699 BCH097702 BCH097239 BCH097706 BCH097720 BCH097721 BCH097726 BCH096826 BCH097739 BCH096829 BCH097740 BCH098239 BCH096831 BCH097756 BCH096837 BCH096840 BCH096843 BCH096852 BCH096845 BCH096848 BCH096855 BCH096857 BCH096859 BCH096861 BCH096863 BCH096864 BCH096824 BCH096825 BCH097757 BCH096819 BCH097760 BCH096808 BCH096809 BCH097761 BCH096810 BCH096823 BCH098804 BCH098520 BCH097598 BCH098823 BCH096792 BCH096793 BCH096795 BCH096797 BCH097772 BCH096798 BCH096802 BCH098763 BCH000934 BCH098761 BCH096776 BCH097540 BCH097557 BCH097558 BCH096777 BCH096778 BCH096774 BCH096780 BCH096781 BCH097559 BCH096786 BCH096783 bch097620 BCH097773 BCH097353 BCH096788 BCH096784 BCH098796 bch097320 bch097613 BCH097774 bch097614 bch097321 bch097340 BCH097604 BCH097792 BCH097795 BCH098407 BCH097799 BCH097800 BCH097803 BCH097805 BCH097808 BCH097814 BCH097815 BCH098318 BCH098322 BCH097684 BCH097685 BCH097686 BCH097689 bch097601 BCH097690 BCH097691 BCH097697 BCH097700 BCH097701 BCH097703 BCH097704 BCH097710 BCH097711 BCH097712 BCH097713 BCH097714 BCH097715 BCH097716 BCH097717 BCH097718 BCH097719 BCH097722 BCH097723 BCH098043 BCH098044 BCH097724 BCH097725 BCH097727 BCH097729 BCH097730 BCH097731 BCH097732 BCH097733 BCH097734 BCH097736 BCH097737 BCH097741 BCH097742 BCH097743 BCH097744 BCH097745 BCH097746 BCH097753 BCH097754 BCH097465 BCH097471 BCH098844 BCH097755 BCH097758 BCH097759 BCH097476 BCH097765 BCH097777 BCH096814 BCH097486 BCH097130 BCH098845 BCH098021 BCH098045 BCH098046 BCH097648 BCH098050 BCH098051 bch098039 BCH098857 BCH097508 bch097615 BCH001133 BCH097537 BCH098797 BCH097608 BCH097501 BCH097502 bch097616 BCH097609 BCH097503 BCH097487 BCH097612 BCH097618 BCH097619 bch097605 bch097606 BCH098017 bch097709 BCH097376 BCH097481 BCH097969 BCH097377 BCH097971 BCH097972 BCH097975 BCH097976 BCH097978 BCH097979 BCH097980 BCH097983 BCH097988 BCH097990 BCH097993 BCH097995 BCH098001 bch097622 bch097676 BCH098011 bch097662 BCH098016 BCH098018 BCH098019 BCH098359 BCH098020 BCH098024 BCH098028 BCH098031 BCH098032 BCH098038 BCH098059 BCH098063 BCH098824 BCH098071 BCH098074 BCH098085 BCH098086 BCH098087 BCH098089 BCH098090 BCH098092 BCH098096 BCH098099 BCH098101 BCH098102 BCH098109 BCH098806 BCH098110 BCH098112 BCH098117 BCH098836 BCH098118 BCH098121 BCH098130 BCH098131 BCH098837 BCH096815 BCH098762 BCH097546 BCH098799 BCH098034 BCH098408 BCH098000 BCH098002 BCH098003 BCH097313 BCH097314 BCH001104 BCH098047 bch098035 BCH098026 BCH098029 BCH098030 BCH098033 BCH098023 BCH098013 BCH096816 BCH098015 BCH098037 BCH098377 BCH098379 BCH098053 BCH098764 BCH098055 BCH097315 BCH097331 BCH098056 BCH097360 BCH001123 BCH098049 BCH098057 BCH097332 BCH098040 BCH098041 BCH098052 BCH098317 BCH098042 BCH098067 BCH098068 BCH098069 bch098070 BCH098064 BCH098065 BCH097698 BCH097252 BCH001162 BCH000560 BCH000753 BCH000932 BCH000933 BCH096817 BCH000970 BCH098409 BCH098410 BCH000972 BCH098777 BCH098789 BCH098778 BCH098240 BCH098241 BCH098242 BCH098211 BCH098220 BCH098212 BCH098213 BCH098214 BCH098215 BCH098216 BCH098221 BCH097310 BCH098206 BCH098223 BCH098224 BCH098243 BCH098225 BCH098226 BCH098227 BCH098228 BCH098207 BCH098244 BCH098208 BCH098245 BCH098413 BCH098217 BCH098218 BCH098209 BCH098210 BCH097818 BCH098253 BCH098231 BCH098250 BCH098252 BCH098254 BCH098082 BCH098137 BCH098233 BCH098236 BCH098219 BCH098237 BCH098255 BCH098257 BCH098258 BCH098261 BCH098385 BCH098759 BCH098734 BCH098790 BCH096834 BCH096835 BCH096838 BCH096839 BCH098380 BCH098381 BCH098550 BCH096841 BCH096842 BCH096844 BCH098386 BCH098387 BCH098388 BCH098390 BCH097333 BCH097358 BCH098741 BCH097750 BCH097764 BCH097768 BCH098302 BCH098303 BCH098405 BCH098406 BCH098402 BCH098403 BCH098404 BCH098394 BCH098395 BCH098397 BCH098398 BCH098399 BCH098400 BCH098401 BCH098418 BCH098419 BCH098420 BCH098422 BCH098423 BCH098424 BCH098429 BCH098452 BCH098287 BCH098846 BCH096846 BCH098821 BCH098721 BCH098500 BCH098505 BCH098508 BCH098531 BCH098540 BCH098541 BCH098542 BCH098543 BCH098544 BCH098545 BCH098546 BCH098547 BCH098549 BCH098551 BCH098476 BCH098552 BCH098553 BCH098554 BCH098477 BCH098495 BCH098555 BCH098744 BCH098745 BCH098557 BCH098558 BCH098559 BCH098560 BCH098360 BCH098362 BCH098522 BCH098523 BCH098524 BCH098525 BCH098526 BCH098527 BCH098528 BCH098529 BCH098530 BCH098803 BCH098807 BCH098564 BCH098565 BCH098566 BCH098567 BCH098569 BCH098570 BCH098825 BCH098571 BCH098572 BCH098576 BCH098862 BCH096847 BCH098720 BCH098722 BCH098792 BCH098791 BCH098805 BCH098723 BCH098587 BCH098793 BCH098747 BCH098749 BCH098490 BCH096849 BCH096851 BCH097300 BCH096854 BCH001087 BCH001150 BCH001154 BCH000639 bch001017 BCH001149 BCH000487 BCH001148 BCH001159 bch000746 BCH000765 BCH001157 BCH000492 BCH000618 BCH001128 BCH000928 BCH000620 BCH000632 bch000749 BCH000434 bch000759 BCH000444 BCH000411 BCH001000 BCH000678 BCH001125 bch000725 BCH001158 BCH001141 BCH000730 BCH000494 BCH001115 BCH000929 BCH000900 BCH000483 BCH001151 BCH001165 BCH001132 BCH001126 BCH001013 BCH001003 BCH000463 BCH000427 BCH000419 bch000711 BCH000522 BCH000551 BCH000424 BCH000664 BCH000770 BCH001058 BCH001131 BCH000782 BCH001101 BCH000617 BCH000992 bch000649 BCH098752 BCH000533 BCH000445 BCH000437 BCH000999 BCH000501 BCH000409 BCH000874 BCH001090 BCH000910 BCH000438 BCH000712 BCH000626 BCH000479 BCH000478 BCH000458 BCH000504 BCH000960 BCH000634 BCH000613 BCH000718 BCH000723 BCH000614 BCH000571 BCH000622 BCH000699 BCH000636 BCH000780 BCH000773 BCH000879 BCH000978 BCH000674 BCH000457 BCH000480 BCH000927 BCH000568 BCH000673 BCH000892 BCH001155 BCH000647 BCH001034 BCH000609 BCH000726 BCH000519 BCH001051 BCH000705 BCH000410 BCH000662 BCH001105 BCH000710 BCH001027 BCH001024 BCH000650 BCH001144 BCH001161 bch000719 BCH000499 BCH000425 BCH000737 BCH000732 BCH000700 bch000679 BCH000513 BCH000937 bch000681 BCH000663 BCH000731 BCH000942 BCH000984 BCH000508 BCH000630 BCH000648 BCH000983 BCH000624 BCH000661 BCH000687 BCH000643 BCH000619 BCH001089 BCH000652 BCH000638 BCH000646 BCH000709 BCH001138 bch000689 BCH000605 bch000682 BCH000641 BCH000781 BCH096952 bch000692 BCH001135 BCH000418 BCH000429 BCH001052 BCH001029 bch000608 BCH001054 BCH000886 BCH000549 BCH000431 BCH000548 BCH000476 BCH000417 BCH000600 BCH000588 BCH000768 BCH000717 BCH000518 bch000919 BCH000511 BCH000466 BCH000729 BCH001139 BCH000756 BCH000604 BCH000578 bch000747 BCH000736 BCH001084 BCH000559 BCH000462 BCH000421 BCH001030 bch000889 BCH001046 BCH000529 BCH000923 BCH000432 BCH000436 BCH000685 BCH000625 BCH001048 BCH001023 BCH001062 BCH000581 BCH000871 BCH001020 BCH000665 BCH001064 BCH000623 BCH001092 BCH001156 BCH000412 BCH001057 BCH000587 BCH000474 BCH000907 BCH001166 BCH000414 BCH000627 BCH000621 BCH000408 BCH001088 BCH001130 BCH000461 BCH001018 BCH001066 BCH001095 BCH000944 BCH001085 BCH001164 BCH000686 BCH096957 BCH096958 BCH096961 BCH096965 BCH097561 BCH097575 BCH098167 BCH096971 BCH096980 BCH096982 BCH096988 BCH096991 BCH096995 BCH097000 BCH097002 BCH097008 BCH097009 BCH097011 BCH097687 BCH097018 BCH097019 BCH097023 BCH097026 BCH097027 BCH097028 BCH097031 BCH097032 BCH097034 BCH097039 BCH097043 BCH097048 BCH097049 BCH096905 BCH096906 BCH096960 BCH097927 BCH097510 BCH097109 BCH097111 BCH097115 BCH097116 BCH097118 BCH097119 BCH097121 BCH097281 BCH097124 BCH097126 BCH097127 BCH097128 BCH097133 BCH097138 BCH097139 BCH097142 BCH097143 BCH097145 BCH097146 BCH097147 BCH097148 BCH097149 BCH097151 BCH097153 BCH097155 BCH097162 BCH097163 BCH097165 BCH097166 BCH097167 BCH097168 BCH097171 BCH097172 BCH097173 BCH097175 BCH097177 BCH097178 BCH097179 BCH097182 BCH097185 bch097922 BCH097186 BCH097187 BCH097190 BCH097192 BCH097193 BCH097195 BCH097197 BCH097256 BCH097258 BCH097261 BCH097262 BCH097266 BCH097267 BCH097268 BCH097270 BCH097271 BCH097274 BCH097276 BCH097277 BCH097278 BCH097280 bch097574 BCH097283 BCH097284 BCH097327 BCH097293 BCH097294 BCH097296 BCH097298 BCH096970 BCH097188 BCH097427 BCH097316 BCH097317 BCH098093 BCH097319 BCH097323 BCH097325 BCH097326 BCH097681 BCH097329 BCH097330 BCH097334 BCH097336 BCH097339 BCH097341 BCH097347 BCH097348 BCH097350 BCH097362 BCH097365 BCH097396 BCH097399 BCH097401 BCH097402 BCH000477 BCH097403 BCH097410 BCH097412 BCH097413 BCH097941 BCH097414 BCH097415 BCH097416 BCH097417 BCH097421 BCH097422 BCH097423 BCH097424 BCH097436 BCH097442 BCH097444 BCH097445 BCH097522 BCH097455 BCH097456 BCH097459 BCH097463 BCH097469 BCH097479 BCH097513 BCH097514 BCH097515 BCH097521 BCH097523 BCH097542 BCH097550 BCH097552 BCH097554 BCH097555 BCH097563 BCH097564 BCH097566 BCH097567 BCH097576 BCH097577 BCH097580 BCH097581 BCH097589 BCH097602 BCH096966 BCH096868 bch097926 BCH097987 BCH097819 BCH097822 BCH097824 BCH097826 BCH097836 BCH097837 BCH097845 BCH097847 BCH097859 BCH097864 BCH097865 BCH097866 BCH097867 BCH097880 BCH097882 BCH097884 BCH097887 BCH097899 BCH097915 BCH097917 BCH097345 BCH097928 BCH097929 BCH097932 BCH097936 BCH096925 BCH097942 BCH096926 BCH097943 BCH098188 BCH096927 BCH097944 BCH096928 BCH096931 BCH096932 BCH096939 BCH096934 BCH096938 BCH096940 BCH096942 BCH096943 BCH096944 BCH096946 BCH096948 BCH096922 BCH096923 BCH097945 BCH096920 BCH097947 BCH096908 BCH096909 BCH097953 BCH096910 BCH096921 BCH098719 BCH098640 BCH097966 BCH098694 BCH096894 BCH096895 BCH096896 BCH096898 BCH097599 BCH096901 BCH096903 BCH098539 BCH001008 BCH098537 BCH096872 bch097584 bch097590 BCH097527 BCH096873 BCH096874 BCH096869 BCH096875 BCH096883 BCH097533 BCH096889 BCH096884 BCH097539 BCH097970 BCH097543 BCH096891 BCH096885 BCH098651 BCH097544 BCH097207 BCH097977 BCH097306 BCH097551 BCH097553 BCH097562 BCH097985 BCH097378 BCH098352 BCH097989 BCH098006 BCH098066 BCH098094 BCH098027 BCH098222 BCH098058 BCH098323 BCH098324 BCH097766 BCH097771 BCH097775 BCH097776 BCH097198 BCH097778 BCH097779 BCH097780 BCH097783 BCH097784 BCH097785 BCH097786 BCH097788 BCH097789 BCH097793 BCH097794 BCH097796 BCH097798 BCH097801 BCH097802 BCH097804 BCH097807 BCH097809 BCH097810 BCH097921 BCH097924 BCH097811 BCH097812 BCH097813 BCH097816 BCH097820 BCH097821 BCH097823 BCH097825 BCH097827 BCH097829 BCH097833 BCH097834 BCH097835 BCH097838 BCH097839 BCH097842 BCH097849 BCH097851 BCH097852 BCH096919 BCH097338 BCH098659 BCH097853 BCH097860 BCH097862 BCH097483 BCH097863 BCH096853 BCH096913 BCH097531 BCH097532 BCH098667 BCH097493 BCH097933 BCH097937 BCH098134 BCH097952 bch097919 bch097920 BCH098674 BCH097512 BCH097324 BCH001050 bch097367 BCH097541 BCH097565 BCH097457 BCH097494 BCH097337 BCH097570 BCH097500 BCH097344 BCH097571 BCH097854 bch097549 bch097556 bch097572 BCH097597 BCH097585 BCH097592 bch097573 BCH098135 BCH097594 BCH098136 BCH098138 BCH098140 BCH098143 BCH098147 BCH098151 BCH098154 BCH098156 BCH098159 BCH098160 BCH098162 BCH098164 BCH098168 BCH097600 BCH097583 BCH098182 BCH097579 BCH098185 BCH098232 BCH098235 BCH098326 BCH098238 BCH098246 BCH098247 BCH098248 BCH098251 BCH098260 BCH098266 BCH098267 BCH098696 BCH098291 BCH098297 BCH098325 BCH098327 BCH098333 BCH098335 BCH098337 BCH098340 BCH098343 BCH098344 BCH098346 BCH098347 BCH098351 BCH098682 BCH098356 BCH098361 BCH098363 BCH098652 BCH098378 BCH098391 BCH098392 BCH098393 BCH098653 BCH096915 BCH098538 BCH098697 BCH098699 bch097895 BCH098354 bch097914 BCH097352 BCH097354 bch097907 bch097911 BCH000572 bch097896 bch097898 BCH097892 BCH097902 BCH097908 bch097894 BCH097504 BCH097518 BCH096917 BCH097183 bch097925 BCH098328 BCH098329 bch097999 BCH098631 BCH097955 bch097984 bch097994 BCH097956 bch097996 BCH001083 bch097997 BCH097957 bch097982 BCH097939 BCH097940 bch097998 BCH098321 BCH097435 BCH098008 BCH098009 BCH098010 BCH098012 BCH098004 BCH098005 BCH098007 BCH097968 BCH001143 BCH001074 BCH001012 BCH001028 BCH001137 BCH096918 BCH001122 BCH098355 BCH098357 BCH001124 BCH098632 BCH098641 BCH098633 BCH098189 BCH098190 BCH098191 BCH098170 BCH098198 BCH098171 BCH098172 BCH096888 BCH098126 BCH098132 BCH098199 BCH098200 BCH098133 BCH098201 BCH098202 BCH098192 BCH098148 BCH098149 BCH098150 BCH098152 BCH098153 BCH098193 BCH098161 BCH098194 BCH098374 BCH098195 BCH098196 BCH098163 BCH098169 BCH098177 BCH098178 BCH098180 BCH098181 BCH098183 BCH098186 BCH097747 BCH097769 BCH097879 BCH098203 BCH098197 BCH098187 BCH098204 BCH098205 BCH098174 BCH098176 BCH098331 BCH098536 BCH098637 BCH098642 BCH096930 BCH096933 BCH096935 BCH097136 BCH098330 BCH098300 BCH098518 BCH096937 BCH096941 BCH096945 BCH098332 BCH098334 BCH098336 BCH098338 BCH098339 BCH098341 BCH098638 BCH098313 BCH098314 BCH098315 BCH098319 BCH098320 BCH098349 BCH098350 BCH098342 BCH098345 BCH098348 BCH098371 BCH098372 BCH098373 BCH098376 BCH098358 BCH098364 BCH098141 BCH098382 BCH098383 BCH098384 BCH098365 BCH098366 BCH098367 BCH098368 BCH098369 BCH098370 BCH098673 BCH097318 BCH098684 BCH098535 BCH098472 BCH098474 BCH098475 BCH098486 BCH098487 BCH098489 BCH098277 BCH098462 BCH098463 BCH098464 BCH098465 BCH098466 BCH098468 BCH098519 BCH098469 BCH098499 BCH098504 BCH098506 BCH098470 BCH098471 BCH098507 BCH098639 BCH098586 BCH098491 BCH098492 BCH098496 BCH098497 BCH098498 BCH098501 BCH098503 BCH098478 BCH098479 BCH098480 BCH098481 BCH098482 BCH098483 BCH098484 BCH098485 BCH098713 BCH098683 BCH098513 BCH098521 BCH098509 BCH098510 BCH098511 BCH098512 BCH098532 BCH098514 BCH098515 BCH098517 BCH098675 BCH096949 BCH098634 BCH098635 BCH098649 BCH098644 BCH098677 BCH098636 BCH098534 BCH098650 BCH098617 BCH098618 BCH098533 BCH096950 BCH096951 BCH096953 BCH096955
• Recalling Firm/ Manufacturer: Heartware, Inc.; 14400 Nw 60th Ave; Miami Lakes FL 33014-2807
• For Additional Information Contact: MCS Customer Service; 877-367-4823
• Manufacturer Reason for Recall: HVAD Battery Charger units manufactured with wrong inductors.
• FDA Determined Cause: Other
• Action: On November 2018 Medtronic sent the following letter to all their consignees: Dear Physician or Healthcare Professional: HeartWare, now a part of Medtronic, has been notified by an outside vendor that a quantity of HVAD battery charger units (see image above) may have been manufactured with an incorrect circuit component. This subset may exhibit one or more of the battery charging bays not fully charging the battery and/or battery charger indicators (LED) not lighting. The behaviors may occur in any individual bay, independent of the other charging bays. In analyzed units, up to 2 charging bays exhibited one of the above behaviors. In all cases, at least 2 of the remaining bays were able to continue to charge batteries as needed. We are not able to predict if, or when, one of the identified battery charger units may malfunction. The potential exists, however, that all circuits responsible for charging batteries and LED function may fail due to the incorrect component. In the population of potentially affected product, Medtronic has observed a malfunction rate of 16.7%. The number of potentially affected battery chargers remaining in distribution is estimated to be 2031 worldwide. These units were distributed between June 2017 and June 2018. Charging units outside of the serial numbers listed in Appendix A, all new manufactured battery chargers, and the individual batteries are not in scope of this advisory. Through November 02, 2018, Medtronic has received zero (0) reports of patient injuries associated with this issue. Patient Management Recommendations We realize that each patient requires unique clinical considerations. In consultation with Medtronics Independent Practitioner Quality Panel (IPQP), the following recommendations are provided: For patients with a HeartWare Battery Charging Unit in the identified list of Serial Numbers (refer to Appendix A): " Instruct patients to monitor the battery charging unit for any of the following beha
• Quantity in Commerce: 2031
• Distribution: Worldwide distribution - US nationwide distribution in the state of AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, and WI. Countries of Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, India, Italy, Latvia, Lebanon, Netherlands, Poland, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and United Kingdom.
• 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.

• PMA Database: PMAs with Product Code = DSQ and Original Applicant = Medtronic