FDA Enforcement Class II Ongoing

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

Recall: Z-2583-2024 · Reported August 21, 2024

Enforcement

Recall Number: Z-2583-2024
Event ID: 94973
Classification: Class II
Status: Ongoing
Product Type: Devices
Firm: Thoratec LLC
Voluntary / Mandated: Voluntary: Firm initiated
Initial Notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Report Date: August 21, 2024
Initiation Date: June 25, 2024
Classification Date: August 13, 2024
Address: 6035 Stoneridge Dr, Pleasanton, CA, 94588-3270, United States

Description

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 Info

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

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

Quantity

694