CLASS II ONGOING Device recall · Reported 21 Jan 2026 · FDA Enforcement Report

CentriMag Blood Pump recalled by Thoratec

Thoratec is recalling CentriMag Blood Pump, distributed nationwide in the US. The recall was initiated on 10 Oct 2025 and the FDA has classified it as Class II.

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Lot, batch or date codesUDI-DI: 07640135140627, 07640135140603, 05415067036414 IFU: Part(Name) Revision: For US: 1. ARTEN600254920 (IFU CentriMag Blood Pump ABT) Rev C 2. ARTEN600254958 (IFU PediMag Blood Pump US ABT) Rev C 3. ARTEN100174794 (CentriMag Adult Pre-connected Pack IFU, US) Rev B 4. ARTEN600230157 (IFU CentriMag Blood Pump ECMO US) Rev D FOR OUS: ARTEN600254935 (IFU CentriMag Blood Pump CAN ABT) Rev C ARTEN600254936 (IFU PediVas Blood Pump Canada ABT) Rev C ARTEN600332205 (IFU CMag VAS-ECMO Pump OUS) Rev A ARTEN600332207 (IFU PVAS VAS-ECMO Pump OUS) Rev A REF 201-20003, 104318, 201-51006, 201-51007, 201-90001 201-90001T don't have associated un-expired batches/serial numbers. REF/Batch(Serial): 102953/10007334, 10007335, 10007336, 10012012, 10012013, 10012014, 10012015, 10012016, 10036179, 10036180, 10036181, 10037990, 10037992, 10037993, 10037995, 10037996, 10046028, 10046029, 10046030, 10046031, 10046032, 10046033, 10058754, 10058755, 10058756, 10061673, 10061675, 10061676, 10061677, 10065946, 10065947, 10065954, 10065955, 10065956, 10071358, 10071359, 10071361, 10073780, 10073781, 10073783, 10082053, 10082055, 10103208, 10103209, 10106345, 10106346, 10106347, 10106348, 10120074, 10120075, 10120076, 10120077, 10122157, 10122158, 10122159, 10125562, 10125563, 10125564, 10125565, 10138336, 10138337, 10138338, 10138339, 10145124, 10145125, 10145126, 10145127, 10164040, 10164041, 10164044, 10168193, 10168194, 10168195, 10168196, 10168197, 10168199, 10168200, 10168201, 10168202, 10168203, 10173214, 10173215, 10206751, 10206752, 10206754, 10211194, 10211195, 10211196, 10211198, 10211199, 10214967, 10214968, 10214969, 10214970, 10214971, 10235009, 10235014, 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20457845, 20457846, 20457847, 20457848, 20457849, 20457850, 20457851, 20457852, 20457853, 20457854, 20457855, 20457856, 20457857, 20457858, 20457859, 20457860), 10805525(20457862, 20457864, 20457865, 20457867, 20457868, 20457869, 20457870, 20457871, 20457872, 20457873, 20457874, 20457875, 20457876, 20457877, 20457878, 20457879), 10834379(20457880, 20457881, 20457882, 20457883, 20457884, 20457885, 20457886, 20457887, 20457888, 20457889, 20457890, 20457891, 20457892, 20457893, 20457894, 20457895, 20457896, 20457897), 10834385(20481824, 20481826, 20481829, 20481832, 20481834, 20481835, 20481839, 20481841), 10834397(20481807, 20481809, 20481812, 20481814, 20481815, 20481821, 20481822, 20481823); CMAEK01/10485765(20284196, 20284197, 20284198, 20284199, 20284200, 20284201, 20284202, 20284203, 20284204, 20284205, 20284206, 20284207, 20284208, 20284209, 20284210, 20284211, 20284212, 20284213), 10485769(20284214, 20284216, 20284217, 20284218, 20284219, 20284220, 20284221, 20284222, 20284223, 20284224, 20284225, 20284226, 20284227, 20284228, 20284229, 20284230, 20284231), 10506836(20261873, 20261874, 20261875, 20261876, 20261877, 20261878, 20261879, 20261880, 20261881, 20261882, 20261883, 20261884, 20261885, 20261886, 20261887, 20261889, 20261890), 10506837(20261891, 20261892, 20261893, 20261894, 20261895, 20261896, 20261897, 20261898, 20261899, 20261900, 20261901, 20261902, 20261903, 20261904, 20261905, 20261906, 20261907, 20261908), 10506839(20261945, 20261946, 20261947, 20261949, 20261950, 20261951, 20261952, 20261953, 20261955, 20261957, 20261958, 20261959, 20261962), 10506840(20261909, 20261911, 20261912, 20261913, 20261914, 20261918, 20261919, 20261920, 20261921, 20261922, 20261924, 20261925, 20261926), 10506841(20261927, 20261928, 20261929, 20261930, 20261931, 20261932, 20261933, 20261934, 20261935, 20261936, 20261937, 20261938, 20261940, 20261943), 10547650(20284269, 20284277), 10547655(20284294, 20284296, 20284297, 20284298, 20284299, 20284300, 20284302, 20284303, 20284304, 20284306, 20284308, 20284310, 20284311), 10605980(20361662, 20361663, 20361664, 20361665, 20361668, 20361669, 20361670), 10605982(20375884, 20375885, 20375887, 20375888, 20375889, 20375890, 20375891, 20375892, 20375895, 20375896, 20375898, 20375899, 20375900, 20375901), 10605987(20375938, 20375939, 20375940, 20375941, 20375942, 20375943, 20375944, 20375945, 20375946, 20375947, 20375948, 20375949, 20375950, 20375951, 20375952, 20375953, 20375954), 10605988(20375902, 20375903, 20375904, 20375905, 20375906, 20375907, 20375908, 20375909, 20375910, 20375911, 20375912, 20375913, 20375914, 20375915, 20375917, 20375918, 20375919), 10605989(20375921, 20375922, 20375924, 20375925, 20375926, 20375927, 20375929, 20375930, 20375931, 20375932, 20375933, 20375934, 20375935, 20375936, 20375937), 10671735(20422760, 20422761, 20422762, 20422763, 20422764, 20422765, 20422766, 20422767, 20422768, 20422769, 20422770, 20422771, 20422772, 20422773, 20422774, 20422775, 20422776), 10671737(20422777, 20422778, 20422779, 20422780, 20422781, 20422782, 20422783, 20422784, 20422785, 20422786, 20422787, 20422789, 20422790, 20422791, 20422792, 20422794), 10671738(20422795, 20422796, 20422797, 20422798, 20422799, 20422800, 20422801, 20422802, 20422803, 20422805, 20422807, 20422808, 20422809, 20422810, 20422811, 20422812), 10715950(20422705, 20422706, 20422707, 20422708, 20422709, 20422710, 20422711, 20422713, 20422715, 20422716, 20422717, 20422718, 20422719, 20422720, 20422721, 20422722), 10715951(20422725, 20422726, 20422728, 20422733, 20422734, 20422735, 20422736, 20422739, 20422740), 10715951(20422725, 20422726, 20422728, 20422733, 20422734, 20422735, 20422736, 20422739, 20422740), 10715952(20422742, 20422743, 20422745, 20422746, 20422747, 20422748, 20422754, 20422755, 20422756, 20422757, 20422758), 10715956(20422814, 20422816, 20422818, 20422819, 20422821, 20422822, 20422823, 20422824, 20422825, 20422826), 10715957(20443495, 20443496, 20443497, 20443498, 20443499, 20443500, 20443501, 20443502, 20443503, 20443504, 20443505, 20443506, 20443507, 20443508, 20443512), 10715958(20443513, 20443514, 20443516, 20443517, 20443518, 20443522, 20443524, 20443525, 20443527, 20443528, 20443530), 10757855(20443533, 20443535, 20443536, 20443537, 20443538, 20443539, 20443540, 20443545, 20443546, 20443547, 20443548), 10757856(20443549, 20443551, 20443552, 20443553, 20443555, 20443556, 20443557, 20443558, 20443560, 20443562, 20443563, 20443564, 20443565, 20443566), 10757858(20446755, 20446761), 10757859(20446726, 20446727, 20446728, 20446729, 20446730, 20446731, 20446732, 20446733, 20446734, 20446735, 20446736, 20446737, 20446738, 20446739, 20446740, 20446741, 20446742, 20446743), 10794274(20457826, 20457827, 20457828, 20457829, 20457830, 20457831, 20457835), 10805518(20481842, 20481846, 20481849, 20481850, 20481851, 20481852, 20481853, 20481854, 20481856, 20481857), 10805519(20481869, 20481871, 20481874, 20481876), 10844705(20513099, 20513100, 20513102, 20513104, 20513105, 20513107, 20513110, 20513111, 20513115), 10844706(20513118, 20513122, 20513123, 20513124, 20513131, 20513133), 10944546(20570873, 20570874, 20570881, 20570882, 20570883, 20570884, 20570885, 20570886, 20570887, 20570888)

Quantity recalled8399

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-1099-2026
FDA event ID: 97784
Recalling firm: Thoratec, Pleasanton, CA
Classification: Class II
Status: Ongoing
Recall initiated: 10 Oct 2025
FDA classified: 15 Jan 2026
Reported: 21 Jan 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Particulate Matter
Device type: Heart & Vascular Devices

Timeline

10 Oct 2025	Recall initiated by company
15 Jan 2026	Classified by FDA	+97 days
21 Jan 2026	Published in enforcement report	+6 days

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

Reason for recall

Acute circulatory support system pump may not fit into the motor and reports received of the pump not being securely locked into the motor using the screw-in locking feature. Failure to properly lock the pump into motor my not cause pump not inserted alarm, and could lead to particulate, increased heat, anxiety, inconvenience, delay in hemodynamic/ECMO support, stroke, embolism, death.

Product as listed by the FDA

CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016; CentriMag RVAD HDE KIT, REF: 104318; CentriMag Pre-connected Pack, REF: CMAEK00; CentriMag VAD KIT, REF: 201-51006, 201-51007, 201-90001 201-90001T; Blood Pump with CentriMag Acute Circulatory Support System for ECMO, REF: CMAEK01. CentriMag Blood Pump is a component to be used with CentriMag Acute Circulatory Support System

Where it was distributed

Worldwide - US Nationwide distribution including in the states of MN, PA, OK, FL, CA, OR, IL, NY, DE, GA, NJ, NC, WI, OH, AZ, AR, TX, TN, MO, MA, MT, KY, NE, WV, VA, ME, ND, AL, CO, DC, MS, IN, MI, CT, SC, WA, NM, MD, HI, ID, IA, LA, UT, RI, NV and the countries of Algeria, Australia, Austria, Bahrain, CANADA, Cayman Islands, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Hong Kong, Italy, Jordan, Kuwait, Lithuania, Macedonia, Malaysia, Mexico, Netherlands, Oman, Peru, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom.

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

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI-DI: 07640135140627, 07640135140603, 05415067036414 IFU: Part(Name) Revision: For US: 1. ARTEN600254920 (IFU CentriMag Blood Pump ABT) Rev C 2. ARTEN600254958 (IFU PediMag Blood Pump US ABT) Rev C 3. ARTEN100174794 (CentriMag Adult Pre-connected Pack IFU, US) Rev B 4. ARTEN600230157 (IFU CentriMag Blood Pump ECMO US) Rev D FOR OUS: ARTEN600254935 (IFU CentriMag Blood Pump CAN ABT) Rev C ARTEN600254936 (IFU PediVas Blood Pump Canada ABT) Rev C ARTEN600332205 (IFU CMag VAS-ECMO Pump OUS) Rev A ARTEN600332207 (IFU PVAS VAS-ECMO Pump OUS) Rev A REF 201-20003, 104318, 201-51006, 201-51007, 201-90001 201-90001T don't have associated un-expired batches/serial numbers. REF/Batch(Serial): 102953/10007334, 10007335, 10007336, 10012012, 10012013, 10012014, 10012015, 10012016, 10036179, 10036180, 10036181, 10037990, 10037992, 10037993, 10037995, 10037996, 10046028, 10046029, 10046030, 10046031, 10046032, 10046033, 10058754, 10058755, 10058756, 10061673, 10061675, 10061676, 10061677, 10065946, 10065947, 10065954, 10065955, 10065956, 10071358, 10071359, 10071361, 10073780, 10073781, 10073783, 10082053, 10082055, 10103208, 10103209, 10106345, 10106346, 10106347, 10106348, 10120074, 10120075, 10120076, 10120077, 10122157, 10122158, 10122159, 10125562, 10125563, 10125564, 10125565, 10138336, 10138337, 10138338, 10138339, 10145124, 10145125, 10145126, 10145127, 10164040, 10164041, 10164044, 10168193, 10168194, 10168195, 10168196, 10168197, 10168199, 10168200, 10168201, 10168202, 10168203, 10173214, 10173215, 10206751, 10206752, 10206754, 10211194, 10211195, 10211196, 10211198, 10211199, 10214967, 10214968, 10214969, 10214970, 10214971, 10235009, 10235014, 10235019, 10235024, 10245539, 10245540, 10245541, 10245542, 10245543, 10256365, 10256366, 10289217, 10289218, 10291590, 10291591, 10301036, 10301037, 10301038, 10301039, 10301040, 10301041, 10301042, 10301043, 10301044, 10303473, 10303476, 10303477, 10303478, 10325561, 10341677, 10342238 10343635, 10343636, 10343637, 10343638, 10343639, 10343640, 10351700, 10351701, 10351702, 10351703, 10351704, 10351707, 10359524, 10359525, 10359526, 10359527, 10359528, 10359529, 10359530, 10359531, 10359532, 10371222, 10371223, 10371224, 10371225, 10371226, 10373595, 10373596, 10373597, 10373598, 10373599, 10391563, 10391564, 10391565, 10391566, 10398007, 10398008, 10398009, 10398010, 10398011, 10399853, 10399854, 10399855, 10399856, 10399857, 10399858, 10399859, 10399860, 10399861, 10399862, 10399866, 10399867, 10410026, 10410027, 10410028, 10410197, 10410198, 10410199, 10411641, 10411642, 10414322, 10414323, 10414324, 10414325, 10414326, 10416065, 10416066, 10416067, 10418871, 10419212, 10424524, 10428901, 10428902, 10428904, 10428905, 10428906, 10456505, 10456506, 10456507, 10456508, 10456509, 10457499, 10457500, 10457502, 10464083, 10464085, 10464086, 10464092, 10498116, 10498117, 10498118, 10517215, 10518978, 10518979, 10518980, 10518981, 10518982, 10528585, 10528587, 10528588, 10530704, 10530705, 10530706, 10535290, 10535294, 10535297, 10535299, 10535300, 10535302, 10541032, 10541033, 10541034, 10541035, 10543873, 10543874, 10550324, 10550325, 10550326, 10550328, 10550329, 10560628, 10560629, 10560630, 10567320, 10567321, 10567322, 10567323, 10571084, 10571085, 10571086, 10571087, 10571088, 10571090, 10588824, 10588825, 10588826, 10591390, 10591391, 10591392, 10591393, 10602157, 10602160, 10602161, 10602162, 10602163, 10602164, 10623578, 10623579, 10623581, 10623582, 10623583, 10632619, 10632625, 10632630, 10639955, 10639956, 10639957, 10639959, 10639960, 10646446, 10646447, 10646449, 10646450, 10646451, 10646452, 10650250, 10650251, 10652470, 10652471, 10652472, 10652473, 10652474, 10652475, 10652477, 10652479, 10659763, 10659764, 10663359, 10663361, 10663363, 10670118, 10670122, 10670123, 10670124, 10671920, 10671921, 10671922, 10671923, 10671925, 10680535, 10680536, 10680538, 10680539, 10680540, 10683369, 10683370, 10683371, 10683372, 10688155, 10688156, 10688157, 10688158, 10688159, 10688160, 10694256, 10694258, 10694260, 10694262, 10694264, 10694266, 10694268, 10694270, 10694272, 10694273, 10694274, 10694275, 10694296, 10712284, 10712285, 10716549, 10716551, 10716552, 10716553, 10716554, 10727906, 10727907, 10727908, 10727909, 10727910, 10727911, 10727912, 10748553, 10748554, 10748556, 10748557, 10771409, 10771411, 10771412, 10773388, 10773389, 10773390, 10773391, 10773392, 10773393, 10773394, 10776304, 10776308, 10776310, 10776316, 10776317, 10783737, 10783738, 10783739, 10783740, 10783741, 10788706, 10788707, 10788708, 10788709, 10788710, 10788711, 10816789, 10816790, 10816791, 10817064, 10817065, 10821308, 10821309, 10821310, 10828333, 10828334, 10828335, 10828336, 10828337, 10832541, 10832543, 10832544, 10832545, 10832547, 10832548, 10834958, 10834959, 10834960, 10834961, 10834962, 10834963, 10834964, 10834965, 10834966, 10834967, 10834968, 10834969, 10875109, 10875110, 10875111, 10875112, 10875113, 10877738, 10877739, 10877740, 10877742, 10877743, 10877744, 10879671, 10879672, 10879673, 10879674, 10879676, 10879677, 10879678, 10879679, 10879680, 10879682, 10879683, 10879684, 10879685, 10879686, 10879687, 10896069, 10896070, 10896071, 10911663, 10911665, 10911667, 10911669, 10911671, 10911675, 10941952, 10941953, 10941954, 10941955, 10941956, 10947110, 10947111, 10947112, 10947113, 10947114, 10947603, 10947604, 10947605, 10947607, 10947608, 10952744, 10952746, 10952747, 10952749, 10952750, 10956143, 10956144, 10956145, 10960853, 10985404, 10985408, 10985409, 10985410, 10989308, 10989309, 10989311, 11013097, 11013099, 11013100, 11013101, 9103442, 9143416, 9143417, 9174168, 9237175, 9237176, 9237177; 201-90010/10012019, 10012020, 10012021, 10012022, 10012023, 10012024, 10012025, 10012026, 10026482, 10026483, 10026484, 10026485, 10026486, 10026487, 10026488, 10026489, 10061666, 10061668, 10061669, 10061671, 10075586, 10075587, 10075588, 10082037, 10082039, 10082040, 10082041, 10106341, 10106342, 10106343, 10106344, 10114497, 10114499, 10114500, 10118096, 10118097, 10118098, 10118099, 10118100, 10118101, 10118102, 10118103, 10122160, 10122161, 10122162, 10122163, 10157219, 10157220, 10157221, 10184547, 10184548, 10184549, 10184551, 10184553, 10184554, 10184555, 10190508, 10190509, 10194010, 10214972, 10214973, 10234422, 10234423, 10234424, 10235052, 10250573, 10250574, 10250576, 10250577, 10256367, 10256368, 10256369, 10256370, 10256371, 10256372, 10256373, 10261919, 10261920, 10261921, 10261923, 10279769, 10333758, 10333759, 10333760, 10339372, 10339373, 10339374, 10343663, 10343664, 10343665, 10351697, 10351698, 10351699, 10379489, 10379490, 10379491, 10383826, 10383827, 10383828, 10383829, 10391724, 10391725, 10391726, 10391727, 10391730, 10391732, 10391733, 10413131, 10413132, 10413133, 10413135, 10413561, 10413565, 10413566, 10418562, 10462022, 10462023, 10462024, 10470479, 10470521, 10470524, 10472542, 10472550, 10474373, 10474374, 10474376, 10474377, 10498175, 10498176, 10501172, 10501173, 10503762, 10528582, 10543891, 10543892, 10552629, 10552630, 10552631, 10560591, 10560620, 10560621, 10560622, 10560623, 10560624, 10567338, 10567342, 10567343, 10567344, 10571082, 10571083, 10586726, 10586727, 10586728, 10591394, 10591395, 10591396, 10598036, 10598037, 10598038, 10598039, 10598040, 10602152, 10602153, 10602154, 10602155, 10602156, 10619564, 10619565, 10619566, 10619567, 10619568, 10621605, 10621606, 10621607, 10621608, 10621611, 10632450, 10632451, 10636575, 10640045, 10640050, 10640051, 10650671, 10650677, 10650680, 10650681, 10659755, 10659756, 10659757, 10659758, 10659759, 10659760, 10659761, 10663352, 10663353, 10663354, 10727899, 10727900, 10727901, 10727902, 10727903, 10727904, 10727905, 10735527, 10735528, 10735530, 10738501, 10739056, 10739065, 10739066, 10739067, 10739068, 10739069, 10739070, 10739071, 10739072, 10748571, 10748573, 10748574, 10778162, 10778164, 10778165, 10797739, 10797742, 10797746, 10815359, 10815362, 10815363, 10815364, 10816785, 10816786, 10816787, 10821305, 10821306, 10821307, 10828329, 10828330, 10828331, 10828332, 10828529, 10832540, 10835410, 10847295, 10847297, 10847298, 10847299, 10847300, 10847301, 10847302, 10847303, 10858660, 10858661, 10859392, 10859400, 10859403, 10859406, 10859407, 10872106, 10872108, 10872109, 10872111, 10872113, 10875119, 10875123, 10875126, 10875128, 10877758, 10877759, 10877760, 10893762, 10893763, 10893764, 10893765, 10893768, 10893769, 11001344, 11001345, 11001347, 9088894, 9088895, 9088897, 9088898, 9088899, 9088900, 9188312, 9230175, 9239396, 9239397, 9239398, 9239879, 9239880, 9239883, 9251990, 9251991, 9251992, 9251993; 201-90016/10104959, 10109004, 10148485, 10148517, 10195550, 10395893, 10477785, 10528583, 10560573, 10579395, 10579396, 10630119, 10665672, 10916780, 10916781, 10969131, 9163847, 9239394; CMAEK00/CMAEK00(20236575, 20236576, 20236577, 20236578, 20236579, 20236580, 20236581, 20236582, 20236583, 20236584, 20236585, 20236586, 20236587, 20236588, 20236589, 20236590, 20236591, 20236592), 10438711(20236593, 20236594, 20236595, 20236596, 20236597, 20236598, 20236599, 20236600, 20236601, 20236602, 20236603, 20236604, 20236605, 20236607, 20236608, 20236609, 20236610), 10451609(20236611, 20236612, 20236613, 20236614, 20236615, 20236616, 20236617, 20236619, 20236620, 20236621, 20236622, 20236623, 20236624, 20236625, 20236626, 20236627, 20236628), 10451610(20256947, 20256948, 20256949, 20256950, 20256951, 20256952, 20256953, 20256955, 20256956, 20256957, 20256958, 20256959, 20256960, 20256961, 20256962, 20256963, 20256964), 10451615(20256965, 20256966, 20256967, 20256968, 20256969, 20256970, 20256971, 20256972, 20256973, 20256974, 20256975, 20256976, 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20513110, 20513111, 20513115), 10844706(20513118, 20513122, 20513123, 20513124, 20513131, 20513133), 10944546(20570873, 20570874, 20570881, 20570882, 20570883, 20570884, 20570885, 20570886, 20570887, 20570888)

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
26 Nov 2025Device	CLASS II	HeartMate 3 Left Ventricular System (LVAS) Kits recalled by Thoratec	Thoratec	Device Malfunction	Nationwide
26 Nov 2025Device	CLASS II	HeartMate II¿ LVAS Implant Kit recalled by Thoratec	Thoratec	Device Malfunction	Nationwide

Other Heart & Vascular Devices recalls

All 6,220

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Device	CLASS II	TufTex¿ Over-the-Wire Embolectomy Catheter recalled	LeMaitre Vascular	Other	Nationwide
14 Oct 2026Device	CLASS II	Endovascular Pack kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Bard Ep Xt Decapolar Steerable, Diagnostic Ep Catheter, 6f recalled	Stryker Sustainability Solutions	Particulate Matter	Nationwide
7 Oct 2026Device	CLASS II	Medical convenience kits containing BD CliniClean Pericare recalled	American Contract Systems	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Medical convenience kits containing BD CliniClean Pericare recalled	American Contract Systems	Device Malfunction	Nationwide