HeartMate 3 System Controllers provided within the following HeartMate 3 Left Ventricular Assist System (LVAS) Implant Kits or distributed separately: HeartMate 3 LVAS Implant Kit, US, Model: 106524US; HeartMate 3 LVAS Implant Kit, OUS, Model: 106524INT; HeartMate 3 System Controller, US, Model: 106531US; HeartMate 3 System Controller, OUS, Model: 106531INT; HeartMate 3 System Controller Low Flow 2.0, Global, Model: 106531LF2

Reason: Left ventricular assist system controller UI membrane/screen may lift along the edge of the controller housing, and if controller is exposed to fluid, ingress may occur, which may damage printed circuit board assemblies, which could result in unexpected and false positive alarms, loss of visual alarms, loss of user interface(use of buttons, loss of visual alarms,etc.), loss of power, and pump stop

Code information: Model/UDI-DI/System Controller Serial Numbers: 106524US/00813024013297/HSC-134168, HSC-134392, HSC-134393, HSC-134394, HSC-134395, HSC-134396, HSC-134397, HSC-134398, HSC-134399, HSC-134400, HSC-134401, HSC-134402, HSC-134403, HSC-134404, HSC-134405, HSC-134406, HSC-134407, HSC-134408, HSC-134409, HSC-134410, HSC-134411, HSC-134432, HSC-134433, HSC-134434, HSC-134436, HSC-134437, HSC-134438, HSC-134440, HSC-134452, HSC-134454, HSC-134502, HSC-134503, HSC-134504, HSC-134505, HSC-134506, HSC-134507, HSC-134508, HSC-134509, HSC-134510, HSC-134511, HSC-134512, HSC-134513, HSC-134514, HSC-134515, HSC-134516, HSC-134517, HSC-134518, HSC-134519, HSC-134520, HSC-134521, HSC-134572, HSC-134573, HSC-134574, HSC-134575, HSC-134576, HSC-134577, HSC-134578, HSC-134579, HSC-134580, HSC-134581, HSC-134582, HSC-134583, HSC-134584, HSC-134585, HSC-134586, HSC-134587, HSC-134588, HSC-134589, HSC-134590, HSC-134591, HSC-134602, HSC-134603, HSC-134604, HSC-134605, HSC-134606, HSC-134607, HSC-134608, HSC-134609, HSC-134610, HSC-134611, HSC-134612, HSC-134613, HSC-134614, HSC-134615, HSC-134616, HSC-134617, HSC-134618, HSC-134619, HSC-134620, HSC-134621, HSC-134662, HSC-134663, HSC-134664, HSC-134665, HSC-134666, HSC-134667, HSC-134668, HSC-134669, HSC-134670, HSC-134671, HSC-134672, HSC-134673, HSC-134674, HSC-134675, HSC-134676, HSC-134677, HSC-134678, HSC-134679, HSC-134680, HSC-134748, HSC-134749, HSC-134750, HSC-134806, HSC-134807, HSC-134808, HSC-134809, HSC-134810, HSC-134811, HSC-134812, HSC-134813, HSC-134814, HSC-134815, HSC-134816, HSC-134818, HSC-134819, HSC-134820, HSC-134821, HSC-134822, HSC-134823, HSC-134824, HSC-134825, HSC-134826, HSC-134827, HSC-134828, HSC-134829, HSC-134830, HSC-134831, HSC-134832, HSC-134833, HSC-134834, HSC-134835, HSC-134836, HSC-134837, HSC-134838, HSC-134839, HSC-134840, HSC-134841, HSC-134842, HSC-134843, HSC-134844, HSC-134845, HSC-134856, HSC-134857, HSC-134858, HSC-134859, HSC-134860, HSC-134861, HSC-134862, HSC-134863, HSC-134864, HSC-134865, HSC-134866, HSC-134867, HSC-134868, HSC-134869, HSC-134870, HSC-134871, HSC-134872, HSC-134873, HSC-134875, HSC-134876, HSC-134877, HSC-134878, HSC-134879, HSC-134880, HSC-134881, HSC-134882, HSC-134883, HSC-134885, HSC-134976, HSC-134977, HSC-134978, HSC-134979, HSC-134980, HSC-134981, HSC-134982, HSC-134983, HSC-134984. 106524INT/00813024011712/HSC-134262, HSC-134263, HSC-134264, HSC-134265, HSC-134266, HSC-134267, HSC-134268, HSC-134269, HSC-134270, HSC-134271, HSC-134272, HSC-134274, HSC-134275, HSC-134276, HSC-134277, HSC-134278, HSC-134279, HSC-134280, HSC-134281, HSC-134282, HSC-134283, HSC-134284, HSC-134285, HSC-134286, HSC-134287, HSC-134288, HSC-134289, HSC-134290, HSC-134291, HSC-134292, HSC-134293, HSC-134294, HSC-134295, HSC-134296, HSC-134297, HSC-134298, HSC-134299, HSC-134300, HSC-134301, HSC-134352, HSC-134353, HSC-134356, HSC-134357, HSC-134358, HSC-134359, HSC-134360, HSC-134361, HSC-134362, HSC-134364, HSC-134365, HSC-134368, HSC-134369, HSC-134371, HSC-134532, HSC-134533, HSC-134534, HSC-134535, HSC-134536, HSC-134537, HSC-134538, HSC-134539, HSC-134540, HSC-134541, HSC-134542, HSC-134543, HSC-134544, HSC-134545, HSC-134546, HSC-134547, HSC-134548, HSC-134549, HSC-134550, HSC-134551, HSC-134552, HSC-134553, HSC-134554, HSC-134555, HSC-134556, HSC-134557, HSC-134558, HSC-134559, HSC-134560, HSC-134561, HSC-134562, HSC-134563, HSC-134564, HSC-134565, HSC-134566, HSC-134567, HSC-134568, HSC-134569, HSC-134570, HSC-134571, HSC-134706, HSC-134707, HSC-134708, HSC-134709, HSC-134710, HSC-134711, HSC-134712, HSC-134713, HSC-134714, HSC-134715, HSC-134716, HSC-134717, HSC-134718, HSC-134719, HSC-134720, HSC-134721, HSC-134722, HSC-134723, HSC-134724, HSC-134725, HSC-134746, HSC-134747, HSC-134778, HSC-134779, HSC-134780, HSC-134781, HSC-134782, HSC-134783, HSC-134784, HSC-134785, HSC-134846, HSC-134848, HSC-134849, HSC-134850, HSC-134851, HSC-134852, HSC-134853, HSC-134854, HSC-134855, HSC-134957, HSC-134958, HSC-134959, HSC-134960, HSC-134961, HSC-134962, HSC-134964, HSC-134965, HSC-134966, HSC-134968, HSC-134969, HSC-134970, HSC-134971, HSC-134972, HSC-134973, HSC-134974, HSC-134975. 106531US/00813024013235/HSC-134242, HSC-134244, HSC-134245, HSC-134246, HSC-134247, HSC-134252, HSC-134253, HSC-134254, HSC-134255, HSC-134256, HSC-134257, HSC-134258, HSC-134259, HSC-134260, HSC-134261, HSC-134302, HSC-134303, HSC-134304, HSC-134305, HSC-134306, HSC-134307, HSC-134309, HSC-134310, HSC-134311, HSC-134312, HSC-134313, HSC-134314, HSC-134315, HSC-134316, HSC-134317, HSC-134318, HSC-134319, HSC-134320, HSC-134321, HSC-134322, HSC-134323, HSC-134324, HSC-134325, HSC-134326, HSC-134327, HSC-134328, HSC-134329, HSC-134330, HSC-134331, HSC-134332, HSC-134333, HSC-134334, HSC-134335, HSC-134336, HSC-134337, HSC-134338, HSC-134339, HSC-134340, HSC-134341, HSC-134342, HSC-134343, HSC-134344, HSC-134345, HSC-134346, HSC-134347, HSC-134348, HSC-134349, HSC-134350, HSC-134351, HSC-134372, HSC-134373, HSC-134374, HSC-134375, HSC-134376, HSC-134377, HSC-134378, HSC-134379, HSC-134380, HSC-134381, HSC-134382, HSC-134383, HSC-134384, HSC-134385, HSC-134386, HSC-134387, HSC-134388, HSC-134389, HSC-134390, HSC-134391, HSC-134412, HSC-134413, HSC-134414, HSC-134415, HSC-134416, HSC-134417, HSC-134418, HSC-134419, HSC-134420, HSC-134422, HSC-134423, HSC-134424, HSC-134425, HSC-134426, HSC-134427, HSC-134428, HSC-134429, HSC-134430, HSC-134431, HSC-134442, HSC-134443, HSC-134444, HSC-134445, HSC-134446, HSC-134447, HSC-134448, HSC-134449, HSC-134450, HSC-134451, HSC-134462, HSC-134463, HSC-134464, HSC-134465, HSC-134466, HSC-134467, HSC-134468, HSC-134469, HSC-134470, HSC-134471, HSC-134472, HSC-134473, HSC-134474, HSC-134475, HSC-134476, HSC-134477, HSC-134478, HSC-134479, HSC-134480, HSC-134481, HSC-134482, HSC-134483, HSC-134484, HSC-134485, HSC-134486, HSC-134487, HSC-134488, HSC-134489, HSC-134490, HSC-134491, HSC-134492, HSC-134493, HSC-134494, HSC-134495, HSC-134496, HSC-134497, HSC-134498, HSC-134499, HSC-134500, HSC-134501, HSC-134522, HSC-134523, HSC-134524, HSC-134525, HSC-134526, HSC-134527, HSC-134528, HSC-134529, HSC-134530, HSC-134531, HSC-134593, HSC-134622, HSC-134623, HSC-134624, HSC-134625, HSC-134626, HSC-134627, HSC-134628, HSC-134629, HSC-134630, HSC-134631, HSC-134632, HSC-134633, HSC-134634, HSC-134635, HSC-134636, HSC-134637, HSC-134638, HSC-134639, HSC-134640, HSC-134641, HSC-134642, HSC-134643, HSC-134644, HSC-134645, HSC-134646, HSC-134647, HSC-134648, HSC-134649, HSC-134650, HSC-134651, HSC-134652, HSC-134653, HSC-134654, HSC-134655, HSC-134656, HSC-134657, HSC-134658, HSC-134659, HSC-134660, HSC-134661, HSC-134682, HSC-134683, HSC-134684, HSC-134685, HSC-134686, HSC-134687, HSC-134688, HSC-134689, HSC-134690, HSC-134691, HSC-134692, HSC-134693, HSC-134694, HSC-134695, HSC-134696, HSC-134697, HSC-134698, HSC-134699, HSC-134700, HSC-134701, HSC-134730, HSC-134736, HSC-134737, HSC-134738, HSC-134739, HSC-134740, HSC-134741, HSC-134742, HSC-134743, HSC-134744, HSC-134745, HSC-134755, HSC-134756, HSC-134757, HSC-134758, HSC-134759, HSC-134760, HSC-134761, HSC-134762, HSC-134763, HSC-134764, HSC-134765, HSC-134766, HSC-134767, HSC-134768, HSC-134769, HSC-134770, HSC-134771, HSC-134772, HSC-134773, HSC-134774, HSC-134775, HSC-134776, HSC-134786, HSC-134787, HSC-134788, HSC-134789, HSC-134790, HSC-134791, HSC-134792, HSC-134793, HSC-134794, HSC-134795, HSC-134796, HSC-134797, HSC-134798, HSC-134799, HSC-134800, HSC-134801, HSC-134802, HSC-134803, HSC-134804, HSC-134805, HSC-134886, HSC-134887, HSC-134888, HSC-134889, HSC-134890, HSC-134891, HSC-134892, HSC-134893, HSC-134894, HSC-134895, HSC-134896, HSC-134897, HSC-134898, HSC-134899, HSC-134900, HSC-134901, HSC-134902, HSC-134903, HSC-134904, HSC-134905, HSC-134906, HSC-134907, HSC-134908, HSC-134909, HSC-134910, HSC-134911, HSC-134912, HSC-134913, HSC-134914, HSC-134915, HSC-134916, HSC-134917, HSC-134918, HSC-134919, HSC-134920, HSC-134921, HSC-134922, HSC-134923, HSC-134924, HSC-134925, HSC-134927, HSC-134933, HSC-134934, HSC-134936, HSC-134937, HSC-134938, HSC-134939, HSC-134940, HSC-134942, HSC-134943, HSC-134944, HSC-134945, HSC-134985, HSC-134996, HSC-134997, HSC-134998, HSC-134999. 106531INT/00813024011842/HSC-134946, HSC-134947, HSC-134948, HSC-134949, HSC-134951, HSC-134952, HSC-134954, HSC-134955, HSC-134986, HSC-134987, HSC-134988, HSC-134989, HSC-134990, HSC-134991, HSC-134992, HSC-134993, HSC-134994. 106531LF2/05415067031105/HSC-133326, HSC-134726, HSC-134729, HSC-134733, HSC-134735, HSC-134752

Distribution pattern: US: MN, PA, FL, IL, NY, DE, AR, NJ, NC, GA, WI, AZ, TN, MO, TX, MA, OH, VA, NE, CA, OK, CO, DC, IN, MI, CT, UT, IA, MD, OR, NM, ME, SC, KY, LA, WA, NV, HI, AL, MS, KS, WV. OUS: Algeria, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia & Herzegovina, Brazil, Bulgaria, Canada, Cayman Islands, Chile, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, India, Iran, Islamic Republic of, Iraq, Ireland, Israel, Italy, Korea, Kuwait, Lebanon, Lithuania, Macedonia, Morocco, Netherlands, New Zealand, Norway, Oman, Palestine, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uzbekistan