令和 5年 9月25日作成

一般的名称： 植込み型補助人工心臓システム
販売名　　： 植込み型補助人工心臓システム HVAD

モデル番号　：1650DE
対象製造番号　　：
BAT650121, BAT650122, BAT650158, BAT650159, BAT650172, BAT650176, BAT650192, BAT650239,
BAT650242, BAT650243, BAT800138, BAT800139, BAT800141, BAT800144, BAT800145, BAT800146,
BAT800147, BAT801097, BAT801387, BAT801535, BAT801563, BAT801590, BAT801609, BAT801630,
BAT801646, BAT801658, BAT801660, BAT801661, BAT801662, BAT801663, BAT801665, BAT801666,
BAT801667, BAT801668, BAT801672, BAT801673, BAT801677, BAT801701, BAT801776, BAT801781,
BAT801787, BAT801812, BAT801843, BAT801860, BAT801861, BAT801867, BAT801871, BAT801874,
BAT801894, BAT801895, BAT801902, BAT801912, BAT801932, BAT801979, BAT802052, BAT802058,
BAT802064, BAT802069, BAT802077, BAT802079, BAT802096, BAT802097, BAT802099, BAT802100,
BAT802102, BAT802104, BAT802105, BAT802108, BAT802110, BAT802115, BAT802117, BAT802118,
BAT802119, BAT802124, BAT802131, BAT802149, BAT802151, BAT802152, BAT802153, BAT802154,
BAT802155, BAT802156, BAT802158, BAT802161, BAT802162, BAT802164, BAT802165, BAT802167,
BAT802169, BAT802182, BAT802183, BAT802191, BAT802195, BAT802226, BAT802238, BAT802241,
BAT802244, BAT802251, BAT802252, BAT802267, BAT802275, BAT802276, BAT802278, BAT802312,
BAT802342, BAT802346, BAT802356, BAT802358, BAT803333, BAT803334, BAT803336, BAT803337,
BAT803338, BAT803339, BAT803340, BAT803342, BAT803343, BAT803347, BAT803348, BAT803350,
BAT803353, BAT803359, BAT803361, BAT803364, BAT803365, BAT803367, BAT803369, BAT803389,
BAT803393, BAT803394, BAT803398, BAT803400, BAT803406, BAT803407, BAT803412, BAT803415,
BAT803423, BAT803426, BAT803437, BAT803452, BAT803455, BAT803465, BAT803472, BAT803475,
BAT803479, BAT803480, BAT803483, BAT803484, BAT803491, BAT803492, BAT803493, BAT803494,
BAT803497, BAT803499, BAT803505, BAT803509, BAT803511, BAT803515, BAT803522, BAT803523,
BAT803524, BAT803525, BAT803527, BAT803529, BAT803537, BAT803538, BAT803541, BAT803542,
BAT803544, BAT803545, BAT803546, BAT803580, BAT803581, BAT803585, BAT803587, BAT803588,
BAT803589, BAT803591, BAT803593, BAT803595, BAT803596, BAT803598, BAT803599, BAT803601,
BAT803603, BAT803604, BAT803612, BAT803775, BAT803788, BAT803800, BAT803801, BAT803802,
BAT803832, BAT803867, BAT803869, BAT803871, BAT803872, BAT803878, BAT803888, BAT803890,
BAT803893, BAT803894, BAT803896, BAT803927, BAT803934, BAT805155, BAT805162, BAT805164,
BAT805170, BAT805171, BAT805172, BAT805173, BAT805174, BAT805179, BAT805180, BAT805181,
BAT805183, BAT805184, BAT805187, BAT805193, BAT805194, BAT805203, BAT805206, BAT805207,
BAT805208, BAT805209, BAT805211, BAT805216, BAT805220, BAT805221, BAT805226, BAT805244,
BAT805260, BAT805266, BAT805281, BAT805282, BAT805284, BAT805285, BAT805290, BAT805291,
BAT805293, BAT805294, BAT806570, BAT806571, BAT806572, BAT806575, BAT806589, BAT806591,
BAT806592, BAT806595, BAT806598, BAT806604, BAT806610, BAT806613, BAT806631, BAT806635,
BAT806637, BAT806638, BAT806640, BAT806642, BAT806670, BAT806671, BAT806674, BAT806675,
BAT806677, BAT806678, BAT806692, BAT806696, BAT806697, BAT806701, BAT806702, BAT806703,
BAT806705, BAT806707, BAT806708, BAT806710, BAT806711, BAT806712, BAT806716, BAT806718,
BAT806720, BAT806721, BAT806722, BAT806724, BAT806839, BAT806840, BAT806841, BAT806842,
BAT806844, BAT806845, BAT806849, BAT806850, BAT806854, BAT806856, BAT806857, BAT806858,
BAT806859, BAT806860, BAT806861, BAT806862, BAT806863, BAT806864, BAT806897, BAT806900,
BAT806916, BAT806917, BAT806918, BAT806919, BAT806920, BAT806921, BAT806922, BAT806925,
BAT806938, BAT806943, BAT806946, BAT806960, BAT806961, BAT806962, BAT806963, BAT806964,
BAT806969, BAT806971, BAT806972, BAT806973, BAT806974, BAT806975, BAT806978, BAT806979,
BAT807141, BAT807324, BAT807327, BAT807328, BAT807330, BAT807332, BAT807337, BAT807339,
BAT807341, BAT807352, BAT807667, BAT807669, BAT807676, BAT807683, BAT807684, BAT807685,
BAT807686, BAT807687, BAT807688, BAT807690, BAT807691, BAT807694, BAT807695, BAT807696,
BAT807702, BAT807703, BAT807705, BAT807706, BAT807707, BAT807714, BAT807716, BAT807717,
BAT807718, BAT807719, BAT807721, BAT807722, BAT807723, BAT807726, BAT807732, BAT807744,
BAT807745, BAT807746, BAT807751, BAT807752, BAT807755, BAT807756, BAT807761, BAT807763,
BAT807765, BAT807766, BAT807768, BAT807769, BAT807770, BAT807771, BAT807773, BAT807775,
BAT807776, BAT807778, BAT807780, BAT807781, BAT808921, BAT808923, BAT808925, BAT808933,
BAT808934, BAT808945, BAT808952, BAT808953, BAT808959, BAT808986, BAT808989, BAT808991,
BAT808994, BAT809011, BAT809024, BAT809044, BAT809051, BAT809053, BAT809066, BAT809067,
BAT809107, BAT809137, BAT809191, BAT809194, BAT809197, BAT809209, BAT809219, BAT809287,
BAT809289, BAT809297, BAT809300, BAT809323, BAT809410, BAT809411, BAT809413, BAT809422,
BAT809424, BAT810715, BAT810868, BAT810945, BAT811095, BAT811617, BAT811618, BAT811619,
BAT811620, BAT811621, BAT811622, BAT811629, BAT811630, BAT811631, BAT811632, BAT811633,
BAT811640, BAT811641, BAT811642, BAT811643, BAT811646, BAT811647, BAT811648, BAT811660,
BAT811662, BAT811663, BAT811665, BAT811687, BAT811820, BAT811822, BAT811823, BAT811824,
BAT811825, BAT811968, BAT812596, BAT812597, BAT812598, BAT812601, BAT812605, BAT812610,
BAT812641, BAT812665, BAT812668, BAT812675, BAT812683, BAT812691, BAT812693, BAT812701,
BAT812708, BAT812717, BAT812736, BAT812835, BAT812881, BAT813015, BAT813022, BAT813026,
BAT813027, BAT813032, BAT813033, BAT813039, BAT813048, BAT813049, BAT813052, BAT813063,
BAT813065, BAT813066, BAT813068, BAT813071, BAT813072, BAT813073, BAT813076, BAT813080,
BAT813082, BAT813084, BAT813130, BAT813131, BAT813132, BAT813134, BAT813140, BAT813143,
BAT813146, BAT813152, BAT813154, BAT813155, BAT813159, BAT813170, BAT813175, BAT813182,
BAT813183, BAT813184, BAT813185, BAT813193, BAT813201, BAT813204, BAT813207, BAT813216,
BAT813278, BAT813279, BAT813287, BAT813288, BAT813292, BAT813293, BAT813296, BAT813299,
BAT813302, BAT813306, BAT813309, BAT813310, BAT813312, BAT813313, BAT813314, BAT813319,
BAT813320, BAT813322, BAT813328, BAT813334, BAT813354, BAT813507, BAT813598, BAT814377,
BAT814500, BAT814510, BAT814519, BAT814520, BAT814594, BAT814610, BAT814617, BAT814618,
BAT814619, BAT814622, BAT814634, BAT814635, BAT814636, BAT814637, BAT814638, BAT814640,
BAT814641, BAT814642, BAT814643, BAT814644, BAT814655, BAT814959, BAT814991, BAT815000,
BAT815013, BAT815014, BAT815016, BAT815019, BAT815020, BAT815115, BAT815116, BAT815122,
BAT815123, BAT815125, BAT815126, BAT815127, BAT815129, BAT815130, BAT815133, BAT815134,
BAT815136, BAT815139, BAT815149, BAT815159, BAT815165, BAT815167, BAT815172, BAT815173,
BAT815174, BAT815176, BAT815180, BAT815181, BAT815186, BAT815297, BAT815358, BAT815388,
BAT815414, BAT815416, BAT815425, BAT815427, BAT815429, BAT815430, BAT815433, BAT815435,
BAT815437, BAT815439, BAT815440, BAT815442, BAT815443, BAT815446, BAT815448, BAT815455,
BAT815456, BAT815458, BAT815459, BAT815461, BAT815465, BAT815469, BAT815470, BAT815471,
BAT815472, BAT815475, BAT815476, BAT815477, BAT815482, BAT815483, BAT815484, BAT815500,
BAT815501, BAT815952, BAT815958, BAT815966, BAT815967, BAT815970, BAT815987, BAT816006,
BAT816008, BAT816010, BAT816014, BAT816015, BAT816018, BAT816021, BAT816026, BAT816032,
BAT816033, BAT816706, BAT816707, BAT816708, BAT816709, BAT816734, BAT816756, BAT816757,
BAT816758, BAT816759, BAT816761, BAT816762, BAT816763, BAT816764, BAT816765, BAT816766,
BAT816767, BAT816768, BAT816769, BAT816770, BAT816771, BAT816772, BAT816773, BAT816775,
BAT816776, BAT816777, BAT816778, BAT816780, BAT816782, BAT816783, BAT816784, BAT816785,
BAT816787, BAT816792, BAT816793, BAT816794, BAT816796, BAT816797, BAT816798, BAT816799,
BAT816800, BAT816801, BAT816802, BAT816803, BAT816805, BAT816807, BAT816811, BAT816812,
BAT816813, BAT816814, BAT816820, BAT816821, BAT816827, BAT816829, BAT816834, BAT816838,
BAT816842, BAT816855, BAT816856, BAT816861, BAT816870, BAT816878, BAT816879, BAT816904,
BAT816913, BAT816937, BAT816946, BAT816951, BAT816954, BAT816962, BAT816968, BAT816969,
BAT816970, BAT816971, BAT816972, BAT816973, BAT816974, BAT816975, BAT816977, BAT816978,
BAT816979, BAT816981, BAT816982, BAT816983, BAT817083, BAT817084, BAT817085, BAT817087,
BAT817088, BAT817090, BAT817091, BAT817092, BAT817093, BAT817095, BAT817096, BAT817097,
BAT817100, BAT817102, BAT817110, BAT817111, BAT817113, BAT817114, BAT817154, BAT817156,
BAT817162, BAT817164, BAT817165, BAT817166, BAT817168, BAT817170, BAT817172, BAT817173,
BAT817183, BAT817207, BAT817237, BAT817238, BAT817246, BAT817249, BAT817251, BAT817261,
BAT817266, BAT817269, BAT817270, BAT817279, BAT817283, BAT817284, BAT817285, BAT817286,
BAT817287, BAT817290, BAT817295, BAT817298, BAT817299, BAT817302, BAT817303, BAT817308,
BAT817309, BAT817312, BAT817319, BAT817367, BAT817370, BAT817371, BAT817372, BAT817373,
BAT817374, BAT817375, BAT817376, BAT817377, BAT817378, BAT817379, BAT817401, BAT817402,
BAT817403, BAT817405, BAT817406, BAT817407, BAT817408, BAT817409, BAT817410, BAT817413,
BAT817415, BAT817417, BAT817418, BAT817420, BAT817421, BAT817422, BAT817423, BAT817424,
BAT817469, BAT817472, BAT817473, BAT817474, BAT817475, BAT817476, BAT817481, BAT817483,
BAT817484, BAT817487, BAT817488, BAT817517, BAT817519, BAT817520, BAT817522, BAT817523,
BAT817528, BAT817529, BAT817531, BAT817533, BAT817534, BAT817658, BAT817823, BAT817828,
BAT817839, BAT817856, BAT817860, BAT817865, BAT817866, BAT817867, BAT817868, BAT817869,
BAT817874, BAT817879, BAT817880, BAT817881, BAT817885, BAT817888, BAT817891, BAT817895,
BAT817906, BAT817931, BAT817932, BAT817946, BAT817948, BAT817950, BAT817952, BAT818026,
BAT818027, BAT818028, BAT818029, BAT818030, BAT818032, BAT818034, BAT818035, BAT818038,
BAT818042, BAT818043, BAT818044, BAT818045, BAT818046, BAT818047, BAT818048, BAT818049,
BAT818176, BAT818191, BAT818199, BAT818201, BAT818202, BAT818217, BAT901379, BAT901382,
BAT901384, BAT901385, BAT901390, BAT901391, BAT901393, BAT901398, BAT901401, BAT901402,
BAT901403, BAT901404, BAT901409, BAT901410, BAT901414, BAT901415, BAT901418, BAT901422,
BAT901426, BAT901427, BAT901429, BAT901431, BAT901433, BAT901434, BAT901435, BAT901437,
BAT901442, BAT901450, BAT901650, BAT901651, BAT901652, BAT901657, BAT901659, BAT901660,
BAT901664, BAT901666, BAT901668, BAT901669, BAT901670, BAT901673, BAT901676, BAT901677,
BAT901680, BAT901681, BAT902102, BAT902103, BAT902104, BAT902105, BAT902109, BAT902110,
BAT902112, BAT902114, BAT902118, BAT902120, BAT902121, BAT902122, BAT902123, BAT902125,
BAT902128, BAT902130, BAT902131, BAT902135, BAT902141, BAT902143, BAT902144, BAT902146,
BAT902147, BAT902148, BAT902343, BAT902344, BAT902345, BAT902346, BAT902347, BAT902349,
BAT902351, BAT902353, BAT902354, BAT902355, BAT902356, BAT902357, BAT902358, BAT902359,
BAT902360, BAT902361, BAT902537, BAT902538, BAT902539, BAT902541, BAT902542, BAT902543,
BAT902544, BAT902545, BAT902546, BAT902548, BAT902549, BAT902550, BAT902551, BAT902552,
BAT902553, BAT902554, BAT902555, BAT902556, BAT902558, BAT902563, BAT902565, BAT902566,
BAT902567, BAT902568, BAT902569, BAT902570, BAT902571, BAT902836, BAT902837, BAT902838,
BAT902839, BAT902840, BAT902841, BAT902844, BAT902848, BAT902849, BAT902850, BAT902851,
BAT902860, BAT903557, BAT903558, BAT903564, BAT903567, BAT904454, BAT904457, BAT904458,
BAT904464, BAT904465, BAT904470, BAT904471, BAT904472, BAT904473, BAT904475, BAT904479,
BAT904481, BAT904488, BAT904491, BAT904493, BAT904495, BAT904496, BAT904499, BAT904500,
BAT904504, BAT904508, BAT904511, BAT904729, BAT904731, BAT904732, BAT904734, BAT904735,
BAT904739, BAT904740, BAT904742, BAT904743, BAT904744, BAT905407, BAT905414, BAT905422,
BAT905431, BAT905531, BAT905533, BAT905539, BAT905546, BAT905547, BAT905548, BAT905555,
BAT905558, BAT905561, BAT905562, BAT905563, BAT905566, BAT905567, BAT905568, BAT905571,
BAT905574, BAT905575, BAT905578, BAT905581, BAT905586, BAT905587, BAT905588, BAT905591,
BAT905593, BAT905603, BAT905605, BAT905606, BAT905608, BAT905609, BAT905611, BAT905613,
BAT905623, BAT905626, BAT905630, BAT905636, BAT905645, BAT905648, BAT905662, BAT905664,
BAT905666, BAT905667, BAT906784, BAT906785, BAT906786, BAT906787, BAT906788, BAT906789,
BAT906790, BAT906791, BAT906792, BAT906793, BAT906794, BAT906795, BAT906798, BAT906799,
BAT906800, BAT906801, BAT906802, BAT906804, BAT906805, BAT906806, BAT906807, BAT906808,
BAT906809, BAT906811, BAT906812, BAT906813, BAT906814, BAT930121, BAT930125, BAT930126,
BAT930127, BAT930128, BAT930129, BAT930537, BAT930539, BAT930540, BAT930541, BAT930750,
BAT930965, BAT930969, BAT930977, BAT930979, BAT930985, BAT930987, BAT930990, BAT930996,
BAT930999, BAT931003, BAT931006, BAT931007, BAT931008, BAT931009, BAT931010, BAT931011,
BAT931014, BAT931015, BAT931016, BAT931017, BAT931018, BAT931019, BAT931020, BAT931021,
BAT931022, BAT931027, BAT931028, BAT931029, BAT931031, BAT931032, BAT931033, BAT931036,
BAT931188, BAT931336, BAT931376, BAT931377, BAT931379, BAT931380, BAT931382, BAT931384,
BAT931385, BAT931386, BAT931389, BAT931390, BAT931394, BAT931398, BAT931399, BAT931400,
BAT931401, BAT931404, BAT931405, BAT931408, BAT931409, BAT931483, BAT931484, BAT931485,
BAT931487, BAT931489, BAT931490, BAT931495, BAT931497, BAT931498, BAT931499, BAT931500,
BAT931501, BAT931514, BAT931515, BAT931517, BAT931539, BAT931551, BAT931982, BAT931983,
BAT931984, BAT931991, BAT931995, BAT931996, BAT931998, BAT932002, BAT932003, BAT932005,
BAT932007, BAT932012, BAT932016, BAT932017, BAT932018, BAT932020, BAT932021, BAT932022,
BAT932027, BAT932028, BAT932029, BAT932032, BAT932033, BAT932035, BAT932039, BAT932048,
BAT932054, BAT932055, BAT932057, BAT932076, BAT932077, BAT932080, BAT932081, BAT932082,
BAT932084, BAT932085, BAT932086, BAT932087, BAT932092, BAT932126, BAT932135, BAT932136,
BAT932139, BAT932140, BAT932155, BAT932180, BAT932339, BAT932353, BAT932358, BAT932373,
BAT932409, BAT932461, BAT932506, BAT932514, BAT932532, BAT932565, BAT932566, BAT932567,
BAT932568, BAT932569, BAT932571, BAT932574, BAT932575, BAT932576, BAT932577, BAT932578,
BAT932582, BAT932735, BAT932790, BAT932812, BAT932818, BAT932819, BAT932855, BAT932860,
BAT932881, BAT932942, BAT932943, BAT932944, BAT932945, BAT932946, BAT932947, BAT932948,
BAT932950, BAT932951, BAT932954, BAT932956, BAT932957, BAT932958, BAT932959, BAT932961,
BAT932962, BAT932964, BAT932966, BAT932968, BAT932971, BAT932973, BAT932975, BAT932976,
BAT932978, BAT932979, BAT932983, BAT932984, BAT932985, BAT933042, BAT933045, BAT933256,
BAT933257, BAT933258, BAT933259, BAT933261, BAT933264, BAT933265, BAT933266, BAT933267,
BAT933268, BAT933269, BAT933270, BAT933271, BAT933274, BAT933275, BAT933276, BAT933277,
BAT933278, BAT933567, BAT933568, BAT933571, BAT933578, BAT933580, BAT933584, BAT933585,
BAT933588, BAT933595, BAT933601, BAT933604, BAT933608, BAT933611, BAT933618, BAT933647,
BAT933650, BAT933652, BAT933657, BAT933659, BAT933670, BAT933695, BAT933696, BAT933698,
BAT933716, BAT933718, BAT933720, BAT933721, BAT933722, BAT933723, BAT933725, BAT933726,
BAT933727, BAT933732, BAT933737, BAT933739, BAT933742, BAT933749, BAT933751, BAT933752,
BAT934081, BAT934082, BAT934083, BAT934097, BAT934098, BAT934100, BAT934101, BAT934103,
BAT934105, BAT934107, BAT934108, BAT934109, BAT934110, BAT934111, BAT934117, BAT934118,
BAT934119, BAT934120, BAT934121, BAT934124, BAT934125, BAT934126, BAT934127, BAT936479,
BAT936480, BAT936482, BAT936485, BAT936486, BAT936490, BAT936491, BAT936492, BAT936494,
BAT936495, BAT936496, BAT936497, BAT936498, BAT936499, BAT936500, BAT936501, BAT936502,
BAT936519, BAT936637, BAT936638, BAT936639, BAT936843, BAT936945, BAT936961, BAT936962,
BAT936963, BAT936968, BAT936975, BAT936976, BAT936978, BAT936979, BAT936980, BAT936981,
BAT936982, BAT936983, BAT936989, BAT936990, BAT936992, BAT937274, BAT937275, BAT937276,
BAT937277, BAT937285, BAT937286, BAT937287, BAT937288, BAT937289, BAT937292, BAT937293,
BAT937295, BAT937296, BAT937298, BAT937299, BAT937300, BAT937301, BAT937302, BAT937303,
BAT937304, BAT937305, BAT937306, BAT937307, BAT937308, BAT937309, BAT937310, BAT937312,
BAT937313, BAT937315, BAT937316, BAT937317, BAT937318, BAT937319, BAT937320, BAT937321,
BAT937322, BAT937324, BAT937325, BAT937326, BAT937327, BAT937328, BAT937537, BAT937553,
BAT937554, BAT937555, BAT937556, BAT937557, BAT937558, BAT937559, BAT937560, BAT937561,
BAT937562, BAT937563, BAT937564, BAT937565, BAT937566, BAT937568, BAT937752, BAT937753,
BAT937755, BAT937756, BAT937757, BAT937761, BAT937762, BAT937763, BAT937764, BAT937765,
BAT937767, BAT937769, BAT937770, BAT937772, BAT937773, BAT937777, BAT937778, BAT937782,
BAT937784, BAT937785, BAT937787, BAT937788, BAT937790, BAT937792, BAT937795, BAT937797,
BAT937798, BAT937799, BAT937800, BAT937801, BAT937802, BAT937805, BAT937806, BAT937808,
BAT937809, BAT937811, BAT937812, BAT937813, BAT937817, BAT937818, BAT937821, BAT937822,
BAT937823, BAT937835, BAT937837, BAT937838, BAT937839, BAT937840, BAT937841, BAT937844,
BAT937845, BAT937846, BAT937849, BAT937852, BAT937853, BAT937854, BAT937856, BAT937857,
BAT937859, BAT937860, BAT937861, BAT937862, BAT937863, BAT937865, BAT937866, BAT937867,
BAT937868, BAT937871, BAT937873, BAT937874, BAT937875, BAT937876, BAT937879, BAT937880,
BAT937881, BAT937882, BAT937883, BAT937885, BAT937886, BAT937887, BAT937888, BAT937889,
BAT937890, BAT937892, BAT937893, BAT937894, BAT937895, BAT937897, BAT937898, BAT937899,
BAT937902, BAT937904, BAT937905, BAT937906, BAT938059, BAT938060, BAT938482, BAT939069,
BAT939071, BAT939072, BAT939074, BAT939075, BAT939076, BAT939078, BAT939079, BAT939081,
BAT939082, BAT939084, BAT939085, BAT939086, BAT939088, BAT939089, BAT939090, BAT939091,
BAT939092, BAT939094, BAT939095, BAT939097, BAT939098, BAT939099, BAT939101, BAT939102,
BAT939103, BAT939105, BAT939106, BAT939107, BAT939108, BAT939109, BAT939110, BAT939111,
BAT939112, BAT939113, BAT939114, BAT939116, BAT939118, BAT939120, BAT939121, BAT939127,
BAT939128, BAT939129, BAT939130, BAT939131, BAT939132, BAT939133, BAT939134, BAT939136,
BAT939137, BAT939138, BAT939139, BAT939140, BAT939141, BAT939142, BAT939143, BAT939144,
BAT939145, BAT939147, BAT939148, BAT939149, BAT939150, BAT939152, BAT939153, BAT939155,
BAT939156, BAT939157, BAT939158, BAT939159, BAT939160, BAT939161, BAT939162, BAT939165,
BAT939166, BAT939168, BAT939169, BAT939171, BAT939173, BAT939174, BAT939175, BAT939176,
BAT939177, BAT939178, BAT940150, BAT940866, BAT940873, BAT940874, BAT940875, BAT940999,
BAT941024, BAT941070, BAT941076, BAT941119, BAT941120, BAT941121, BAT941122, BAT941123,
BAT941124, BAT941125, BAT941126, BAT941127, BAT941129, BAT941130, BAT941131, BAT941132,
BAT941133, BAT941145, BAT941147, BAT941148, BAT941149, BAT941151, BAT941152, BAT941153,
BAT941154, BAT941160, BAT941162, BAT941164, BAT941165, BAT941167, BAT941168, BAT941170,
BAT941171, BAT941172, BAT941173, BAT941174, BAT941225, BAT941226, BAT941228, BAT941229,
BAT941231, BAT941233, BAT941234, BAT941236, BAT941237, BAT941240, BAT941241, BAT941243,
BAT941245, BAT941246, BAT941247, BAT941249, BAT941251, BAT941253, BAT941254, BAT941255,
BAT941256, BAT941257, BAT941259, BAT941262, BAT941263, BAT941747, BAT941750, BAT941874,
BAT941880, BAT941886, BAT941897, BAT941935, BAT941936, BAT941937, BAT941942, BAT941943,
BAT941944, BAT941948, BAT941955, BAT941959, BAT941960, BAT941961, BAT941962, BAT941963,
BAT941980, BAT941981, BAT941986, BAT941987, BAT941988, BAT941992, BAT941993, BAT941995,
BAT941996, BAT941997, BAT941999, BAT942008, BAT942010, BAT942016, BAT942017, BAT942024,
BAT942027, BAT942035, BAT942037, BAT942038, BAT942193, BAT942199, BAT942203, BAT942204,
BAT942206, BAT942207, BAT942209, BAT942211, BAT942212, BAT942214, BAT942217, BAT942218,
BAT942222, BAT942224, BAT942229, BAT942230, BAT942235, BAT942236, BAT942240, BAT942241,
BAT942242, BAT942248, BAT942251, BAT942254, BAT942256, BAT942260, BAT942261, BAT942262,
BAT942264, BAT942265, BAT942267, BAT942270, BAT942271, BAT942272, BAT942273, BAT942275,
BAT942276, BAT942277, BAT942278, BAT942279, BAT942280, BAT942281, BAT942282, BAT942283,
BAT942284, BAT942286, BAT942287, BAT942290, BAT942292, BAT942293, BAT942296, BAT942297,
BAT942299, BAT942302, BAT942303, BAT942304, BAT942307, BAT942309, BAT942310, BAT942311,
BAT942313, BAT942314, BAT942315, BAT942316, BAT942317, BAT942318, BAT942319, BAT942321,
BAT942322, BAT942323, BAT942324, BAT942325, BAT942327, BAT942328, BAT942329, BAT942330,
BAT942331, BAT942332, BAT942333, BAT942334, BAT942335, BAT942336, BAT942337, BAT942338,
BAT942339, BAT942340, BAT942343, BAT942344, BAT942345, BAT942347, BAT942348, BAT942349,
BAT942350, BAT942352, BAT942355, BAT942356, BAT942360, BAT942372, BAT942373, BAT942453,
BAT942642, BAT942833, BAT943128, BAT943129, BAT943131, BAT943134, BAT943135, BAT943599,
BAT943613, BAT943887, BAT943888, BAT943890, BAT943891, BAT943896, BAT943897, BAT943898,
BAT943899, BAT943900, BAT943901, BAT943905, BAT943906, BAT943907, BAT943910, BAT943913,
BAT943915, BAT943916, BAT943917, BAT943920, BAT943922, BAT943924, BAT943926, BAT943927,
BAT943928, BAT943930, BAT943931, BAT943933, BAT943934, BAT943937, BAT943939, BAT943942,
BAT943947, BAT943948, BAT943949, BAT943951, BAT943952, BAT943955, BAT943956, BAT943957,
BAT943958, BAT943961, BAT943962, BAT943963, BAT943964, BAT943972, BAT943973, BAT943976,
BAT943977, BAT943978, BAT943979, BAT943980, BAT944495, BAT944499, BAT944510, BAT944516,
BAT944517, BAT944518, BAT944519, BAT944521, BAT944522, BAT944523, BAT944525, BAT944526,
BAT944528, BAT944531, BAT944532, BAT944533, BAT944534, BAT944537, BAT944538, BAT944540,
BAT944541, BAT944542, BAT944543, BAT944549, BAT944550, BAT944551, BAT944552, BAT944553,
BAT944555, BAT944556, BAT944557, BAT944558, BAT944559, BAT944560, BAT944561, BAT944566,
BAT944567, BAT944568, BAT944569, BAT944570, BAT944572, BAT944574, BAT944575, BAT944577,
BAT944578, BAT944579, BAT944581, BAT944583, BAT944585, BAT944586, BAT944588, BAT944589,
BAT944590, BAT944591, BAT944592, BAT944593, BAT944595, BAT944599, BAT944603, BAT944605,
BAT944606, BAT944607, BAT944610, BAT944611, BAT944613, BAT944614, BAT944721, BAT944723,
BAT945040, BAT945045, BAT945046, BAT945056, BAT945061, BAT945068, BAT945071, BAT945082,
BAT945087, BAT945090, BAT945091, BAT945099, BAT945100, BAT945101, BAT945103, BAT945105,
BAT945120, BAT945121, BAT945123, BAT945125, BAT945130, BAT945132, BAT945133, BAT945134,
BAT945138, BAT945140, BAT945144, BAT945145, BAT945147, BAT945149, BAT945150, BAT945151,
BAT945152, BAT945162, BAT945165, BAT945168, BAT945169, BAT945170, BAT945171, BAT945172,
BAT945173, BAT945174, BAT945175, BAT945176, BAT945177, BAT945178, BAT945179, BAT945181,
BAT945182, BAT945183, BAT945210, BAT945211, BAT945212, BAT945214, BAT945215, BAT945224,
BAT945228, BAT945229, BAT945230, BAT945239, BAT945240, BAT945256, BAT945271, BAT945274,
BAT945285, BAT945290, BAT945311, BAT945369, BAT945452, BAT945454, BAT945455, BAT945456,
BAT945457, BAT945461, BAT945463, BAT945464, BAT945471, BAT945475, BAT945478, BAT945481,
BAT945482, BAT945485, BAT945487, BAT945488, BAT945491, BAT945492, BAT945493, BAT945499,
BAT945509, BAT945510, BAT945549, BAT945551, BAT945553, BAT945554, BAT945557, BAT945559,
BAT945561, BAT945567, BAT945573, BAT945575, BAT945576, BAT945577, BAT945584, BAT945585,
BAT945650, BAT945651, BAT945661, BAT945683, BAT945701, BAT945703, BAT945709, BAT945710,
BAT945717, BAT945722, BAT945726, BAT945730, BAT945731, BAT945734, BAT945741, BAT945743,
BAT945744, BAT945745, BAT945746, BAT945747, BAT945751, BAT945758, BAT945761, BAT945765,
BAT945767, BAT945768, BAT945769, BAT945770, BAT945771, BAT945772, BAT945773, BAT945775,
BAT945776, BAT945784, BAT945788, BAT945791, BAT945792, BAT945794, BAT945796, BAT945799,
BAT945800, BAT945801, BAT945803, BAT945805, BAT945807, BAT945808, BAT945809, BAT945810,
BAT945819, BAT945831, BAT945832, BAT945833, BAT945835, BAT945837, BAT945840, BAT945842,
BAT945843, BAT945844, BAT945846, BAT945847, BAT945848, BAT945850, BAT945854, BAT945861,
BAT945864, BAT945869, BAT945873, BAT945874, BAT945875, BAT945877, BAT945881, BAT945883,
BAT945884, BAT945885, BAT945890, BAT945895, BAT945896, BAT945899, BAT945903, BAT945905,
BAT945922, BAT945925, BAT945926, BAT945941, BAT945942, BAT945944, BAT945946, BAT945948,
BAT945952, BAT945953, BAT945956, BAT945957, BAT945960, BAT945963, BAT945967, BAT945979,
BAT945982, BAT946000, BAT946001, BAT946005, BAT946007, BAT946011, BAT946019, BAT946021,
BAT946024, BAT946030, BAT946032, BAT946033, BAT946034, BAT946036, BAT946040, BAT946041,
BAT946042, BAT946043, BAT946045, BAT946046, BAT946047, BAT946049, BAT946051, BAT946054,
BAT946055, BAT946057, BAT946058, BAT946059, BAT946060, BAT946062, BAT946065, BAT946076,
BAT946090, BAT946106, BAT946109, BAT946110, BAT946111, BAT946113, BAT946122, BAT946129,
BAT946131, BAT946133, BAT946134, BAT946137, BAT946139, BAT946141, BAT946144, BAT946145,
BAT946147, BAT946149, BAT946153, BAT946154, BAT946155, BAT946158, BAT946159, BAT946160,
BAT946163, BAT946165, BAT946166, BAT946187, BAT946188, BAT946191, BAT946192, BAT946193,
BAT946197, BAT946198, BAT946200, BAT946201, BAT946203, BAT946233, BAT946244, BAT946280,
BAT946282, BAT946290, BAT946293, BAT946297, BAT946305, BAT946306, BAT946307, BAT946310,
BAT946311, BAT946316, BAT946317, BAT946322, BAT946330, BAT946332, BAT946335, BAT946336,
BAT946337, BAT946341, BAT946348, BAT946393, BAT946394, BAT946397, BAT946399, BAT946404,
BAT946406, BAT946407, BAT946408, BAT946410, BAT946411, BAT946413, BAT946415, BAT946416,
BAT946418, BAT946419, BAT946421, BAT946422, BAT946424, BAT946429, BAT946431, BAT946435,
BAT946440, BAT946446, BAT946448, BAT946450, BAT946451, BAT946455, BAT946460, BAT946466,
BAT946470, BAT946472, BAT946479, BAT946480, BAT946482, BAT946484, BAT946491, BAT946501,
BAT946503, BAT946505, BAT946508, BAT946529, BAT946534, BAT946542, BAT946545, BAT946546,
BAT946547, BAT946553, BAT946558, BAT946562, BAT946569, BAT946572, BAT946573, BAT946603,
BAT946618, BAT946626, BAT946632, BAT946635, BAT946637, BAT946639, BAT946642, BAT946643,
BAT946650, BAT946657, BAT946663, BAT946671, BAT946675, BAT946679, BAT946683, BAT946701,
BAT947120, BAT947125, BAT947129, BAT947130, BAT947134, BAT947144, BAT947150, BAT947156,
BAT947164, BAT947174, BAT947179, BAT947180, BAT947181, BAT947187, BAT947188, BAT947200,
BAT947203, BAT947210, BAT947219, BAT947222, BAT947225, BAT947229, BAT947234, BAT947245,
BAT947286, BAT947295, BAT947297, BAT947300, BAT947310, BAT947331, BAT947333, BAT947337,
BAT947343, BAT947377, BAT947739, BAT948294, BAT948332, BAT948428, BAT948482, BAT948537,
BAT948545, BAT948602, BAT948615, BAT948617, BAT948618, BAT948619, BAT948631, BAT948637,
BAT948646, BAT948652, BAT948654, BAT948656, BAT948657, BAT948718, BAT948734, BAT948735,
BAT948765, BAT948893, BAT948894, BAT948896, BAT948907, BAT948910, BAT948913, BAT948918,
BAT948919, BAT948920, BAT948924, BAT948925, BAT948926, BAT948928, BAT948936, BAT948940,
BAT949033, BAT949034, BAT949035, BAT949038, BAT949039, BAT949041, BAT949043, BAT949044,
BAT949045, BAT949046, BAT949047, BAT949048, BAT949053, BAT949054, BAT949055, BAT949057,
BAT949058, BAT949059, BAT949060, BAT949061, BAT949062, BAT949063, BAT949064, BAT949065,
BAT949066, BAT949067, BAT949070, BAT949071, BAT949072, BAT949073, BAT949076, BAT949077,
BAT949079, BAT949080, BAT949081, BAT949083, BAT949084, BAT949085, BAT949086, BAT949087,
BAT949090, BAT949091, BAT949096, BAT949099, BAT949103, BAT949109, BAT949121, BAT949126,
BAT949127
数量　　　　：2473台
出荷時期　　：平成31年1月31日〜令和5年9月11日

製造販売業者の名称　： 日本メドトロニック株式会社
製造販売業者の所在地： 東京都港区港南一丁目２番７０号
許可の種類　　　　　： 第一種医療機器製造販売業
許可番号　　　　　　： 13B1X00261
製造業者：HeartWare, Inc.
所在国：米国

海外製造元の調査により、バッテリーの電気的障害が確認されました。
バッテリーと、コントローラまたは充電器との電気的な接続時、バッテリーを制御するソフトウェアのモード設
定と電子チップが相互に影響し、過電圧が発生することで電気的障害を引き起こすと考えられます。
今般、本事象の発生低減を図るために、モード設定の変更を行ったバッテリーの承認事項一部変更承認を取得い
たしましたので、既存品との交換作業を自主回収として実施いたします。

バッテリーの電気的障害により、充電不良、コントローラへの電力供給不良、あるいはインジケータ不良が発生
する可能性があります。
本不具合に関連した事象が発生した場合、バッテリーまたはコントローラのインジケータ表示、接続認識音、並
びにアラームにより検知可能です。
コントローラに接続されるもう片方の電源により電力供給は継続されるため、直ちに電源喪失に至ることはな
く、他のバッテリー、コントローラACアダプタ、並びにコントローラDCアダプタへの交換により対処可能である
ため、重篤な健康被害が発生することは無いと考えます。なお、国内において、バッテリーの電気的障害が直接
の要因となった重篤な健康被害の報告は受けておりません。

令和5年9月25日　情報提供の開始

本品は、心臓移植適応の重症心不全患者で、薬物療法や体外式補助人工心臓などの補助循環法によっても継続し
た代償不全に陥っており、かつ、心臓移植以外には救命が困難と考えられる症例に対して、心臓移植までの循環
改善に使用される。

対象製品の所在は把握しておりますので、該当する医療機関に対して情報提供の上、回収を速やかに実施致しま
す。

担当者　： 品質・市販後安全管理
　　　　　 山下 稔貴、中岡 まり
連絡先　： 日本メドトロニック株式会社
　　　　　 東京都港区港南一丁目2番70号
電話番号： 03-6776-0040
FAX番号 ： 03-6774-4675