CLASS II ONGOING Device recall · Reported 21 Aug 2024 · FDA Enforcement Report

HeartMate 3 System Controllers provided within recalled by Thoratec

Thoratec is recalling HeartMate 3 System Controllers provided within the following HeartMate 3 Left Ventricular, distributed in 42 states. The recall was initiated on 25 Jun 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel/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

Quantity recalled694

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2583-2024
FDA event ID: 94973
Recalling firm: Thoratec, Pleasanton, CA
Classification: Class II
Status: Ongoing
Recall initiated: 25 Jun 2024
FDA classified: 13 Aug 2024
Reported: 21 Aug 2024
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

25 Jun 2024	Recall initiated by company
13 Aug 2024	Classified by FDA	+49 days
21 Aug 2024	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

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

Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Thoratec

All 29

Reported	Class	Recall	Company	Reason	Where
24 Jun 2026Device	CLASS II	HeartMate HM 11V Li-ion Backup Battery, ABT recalled by Thoratec	Thoratec	Device Malfunction	Nationwide
24 Jun 2026Device	CLASS II	HeartMate 3 Left Ventricular System (LVAS) Kits recalled by Thoratec	Thoratec	Device Malfunction	Nationwide
24 Jun 2026Device	CLASS II	HeartMate 3" System Controller recalled by Thoratec	Thoratec	Device Malfunction	Nationwide
21 Jan 2026Device	CLASS II	CentriMag Blood Pump recalled by Thoratec	Thoratec	Particulate Matter	Nationwide
26 Nov 2025Device	CLASS II	HeartMate 3 Left Ventricular System (LVAS) Kits recalled by Thoratec	Thoratec	Device Malfunction	Nationwide

Other Other Medical Devices recalls

All 13,950

Reported	Class	Recall	Company	Reason	Where
28 Oct 2026Device	CLASS II	Medline Drape C-section W/Pouch ST 7/CS, Medline Product Number recalled	Medline Industries	Other	Nationwide
28 Oct 2026Device	CLASS II	Medline medical convenience kits labeled as recalled	Medline Industries	Other	Nationwide
28 Oct 2026Device	CLASS II	Medline medical convenience kits labeled as: Fetal Surgery Cds-lf recalled	Medline Industries	Other	Nationwide
28 Oct 2026Device	CLASS II	Medline Drape C-section Fen Clr Screen W, Medline Product Number recalled	Medline Industries	Other	Nationwide
28 Oct 2026Device	CLASS II	Medline medical convenience kits labeled as: C-section Pack recalled	Medline Industries	Other	Nationwide