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Thoratec HeartMate 3 recallZ-2583-2024 · Thoratec LLC · initiated Jun 25, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Thoratec LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Process design

What the company is doing

On 6/25/24, verbal and email communications were initiated informing customers of the following: 1) Carefully inspect the controller at the edge near the display button to confirm the UI membrane is not lifted (refer to provided visual examples). 2) Report Controllers with lifted UI membrane by contacting Firm's Technical Support at 1-800-456-1477. 3) Reinforce requirement as listed on Page 2-11 "System Controller Warnings and Cautions" in the IFU to patients to protect controller from water. Advise them to follow instructions to avoid direct exposure to water; and communicate risk of continuous, steady exposure to water. 4) Reinforce requirement to patient to perform the daily self-test to verify the display works appropriately as listed on Page 2-29 "Performing a System Controller Self Test". Patients should contact the hospital in the event of display issues. Firm will follow-up with a formal notification about the lifted UI membrane.

Recall details

Recall number
Z-2583-2024
Status
Open, Classified
Initiated by the company
Jun 25, 2024
Posted by the FDA
Aug 13, 2024
Recalling firm
Thoratec LLC
Quantity
694
Product code
DSQ
FDA submissions
P160054
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

Product description

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

Code information (models, lots, serial numbers)

Show the full code information (9k characters)

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

Devices named in this recall

3 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

24 devices cleared under P160054 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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