Boston Scientific Corporation medical device recall: Accolade Sr Sl

Reason for recall

Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

What the classification means

• Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.

About this recall

The firm started this recall on Aug 20, 2025. FDA classified it 51 days later, on Oct 10, 2025. This recall event covers 27 separate products, each with its own FDA recall number. Distribution reported by FDA: Worldwide Boston Scientific Corporation has 169 recalls in our records.

Recalled products (27)

• Z-0079-2026 Class I Ongoing

  ACCOLADE SR SL (Model L300)

  Codes / lots: GTIN 00802526558900, Serial Numbers: 464190, 464192, 464197, 464228, 464229, 464230, 464238, 464258, 464279, 464295, 464296, 464316, 464321, 464358, 464360, 464361, 464362, 464363, 464369, 464371, 464378, 464383, 464384, 464392, 464393, 464398, 464400, 464406, 464408, 464409, 464410, 464411, 464414, 464425, 464427, 464430, 464432, 464435, 464437, 464441, 464442, 464443, 464451, 464455, 464456, 464466, 464469, 464474, 464480, 464484, 464485, 464487, 464488, 464489, 464496, 464502, 464503, 464504, 464507, 464520, 464529, 464531, 464534, 464538, 464544, 464547, 464551, 464556, 464558, 464560, 464566, 464571, 464577, 464583, 464585, 464586, 464587, 464588, 464591, 464592, 464604, 464608, 464611, 464617, 464623, 464635, 464637, 464639, 464642, 464643, 464653, 464660, 464662, 464664, 464665, 464667, 464668, 464681, 464683, 464685, 464692, 464697, 464698, 464699, 464700, 464706, 464707,…

  Quantity: 16,077 units

• Z-0080-2026 Class I Ongoing

  ACCOLADE DR SL (Model L301)

  Codes / lots: GTIN 00802526558924, Serial Numbers: 100056, 100092, 100111, 100120, 100122, 100125, 100127, 100134, 100136, 100137, 100142, 100144, 100147, 100154, 100156, 100160, 100161, 100162, 100168, 100177, 100179, 100183, 100184, 100185, 100190, 100192, 100200, 100206, 100207, 100214, 100217, 100224, 100226, 100227, 100230, 100231, 100234, 100235, 100236, 100237, 100238, 100246, 100253, 100255, 100258, 100261, 100268, 100269, 100277, 100279, 100284, 100285, 100288, 100291, 100293, 100299, 100302, 100303, 100304, 100307, 100313, 100316, 100323, 100326, 100334, 100337, 100341, 100342, 100344, 100345, 100353, 100355, 100356, 100359, 100366, 100368, 100373, 100374, 100377, 100388, 100389, 100391, 100394, 100396, 100399, 100402, 100411, 100419, 100421, 100426, 100428, 100429, 100437, 100440, 100441, 100445, 100447, 100448, 100449, 100450, 100454, 100456, 100457, 100460, 100467, 100468, 100469,…

  Quantity: 32,695 units

• Z-0081-2026 Class I Ongoing

  ACCOLADE SR SL MRI (Model L310)

  Codes / lots: GTIN 00802526558948, Serial Numbers: 701140, 701954, 702152, 702176, 702278, 702560, 702997, 702998, 703023, 703075, 703125, 703128, 703138, 703169, 703172, 703201, 703203, 703251, 703253, 703272, 703307, 703324, 703331, 703343, 703395, 703427, 703447, 703451, 703458, 703504, 703508, 703534, 703538, 703546, 703547, 703628, 703656, 703754, 703790, 703839, 704235, 704285, 704300, 704307, 704351, 704493, 704495, 704563, 704590, 704877, 705061, 705070, 705078, 705085, 705105, 705130, 705163, 705169, 705192, 705196, 705225, 705253, 705261, 705270, 705443, 705446, 705523, 705526, 705529, 705541, 705545, 705546, 705573, 705579, 705584, 705587, 705593, 705612, 706491, 707091, 707196, 707376, 707777, 708269, 708354, 709408, 709434, 709521, 709549, 709575, 709578, 709659, 709678, 709687, 709710, 709744, 709750, 709773, 709794, 709813, 709824, 709844, 709862, 709905, 709918, 709930, 709945,…

  Quantity: 50,135 units

• Z-0082-2026 Class I Ongoing

  ACCOLADE DR SL MRI (Model L311)

  Codes / lots: GTIN 00802526558962, Serial Numbers: 200737, 202944, 203132, 203273, 203512, 203621, 203903, 204448, 204712, 204767, 204877, 204938, 205006, 205007, 205020, 205029, 205055, 205063, 205068, 205069, 205076, 205077, 205079, 205088, 205116, 205218, 205226, 205261, 205328, 205330, 205339, 205354, 205355, 205375, 205398, 205400, 205423, 205457, 205515, 205544, 205552, 205601, 205613, 205633, 205642, 205645, 205651, 205656, 205668, 205694, 205699, 205705, 205713, 205716, 205717, 205719, 205728, 205772, 205778, 205808, 205816, 205818, 205830, 205833, 205835, 205838, 205870, 205896, 205956, 205983, 205995, 206085, 206094, 206117, 206123, 206144, 206152, 206157, 206252, 206260, 206265, 206285, 206325, 206375, 206404, 206408, 206411, 206505, 207204, 207462, 207887, 208016, 208046, 208192, 208212, 208325, 208368, 208372, 208379, 208434, 208449, 208461, 208465, 208471, 208489, 208632, 208636,…

  Quantity: 90,931 units

• Z-0083-2026 Class I Ongoing

  ACCOLADE DR EL (Model L321)

  Codes / lots: GTIN 00802526558986, Serial Numbers: 100004, 100005, 100033, 100051, 100054, 100058, 100075, 100076, 100092, 100106, 100107, 100109, 100111, 100115, 100116, 100117, 100118, 100119, 100120, 100121, 100125, 100127, 100128, 100130, 100132, 100133, 100134, 100135, 100137, 100141, 100144, 100147, 100149, 100150, 100158, 100159, 100160, 100161, 100162, 100164, 100165, 100168, 100169, 100173, 100175, 100177, 100178, 100179, 100181, 100182, 100184, 100186, 100187, 100188, 100190, 100191, 100193, 100195, 100197, 100199, 100202, 100206, 100209, 100212, 100215, 100220, 100223, 100227, 100228, 100231, 100233, 100234, 100235, 100236, 100237, 100238, 100239, 100241, 100242, 100243, 100244, 100245, 100246, 100248, 100249, 100250, 100251, 100253, 100255, 100257, 100259, 100260, 100261, 100262, 100265, 100266, 100267, 100273, 100274, 100277, 100280, 100281, 100283, 100286, 100287, 100288, 100289,…

  Quantity: 7,488 units

• Z-0084-2026 Class I Ongoing

  ACCOLADE DR EL MRI (Model L331)

  Codes / lots: GTIN 00802526559006, Serial Numbers: 102138, 102172, 102192, 102209, 102210, 102229, 102231, 102232, 102233, 102237, 102239, 102243, 102255, 102256, 102261, 102263, 102265, 102266, 102267, 102269, 102273, 102274, 102277, 102290, 102358, 102389, 102392, 102422, 102435, 102438, 102441, 102445, 102448, 102460, 102464, 102466, 102474, 102503, 102513, 102564, 102624, 102625, 110031, 110032, 110057, 110099, 110165, 110168, 110174, 110176, 110261, 110262, 110280, 110293, 110318, 110371, 110433, 110436, 110496, 110507, 110517, 110550, 110718, 110749, 110768, 110814, 110837, 110841, 110846, 110865, 110876, 110932, 110933, 110938, 110939, 110953, 110965, 110984, 110985, 110989, 111044, 111074, 111095, 111104, 111116, 111143, 111160, 111171, 111172, 111174, 111184, 111186, 111228, 111241, 111245, 111254, 111272, 111331, 111332, 111339, 111340, 111341, 111342, 111344, 111367, 111375, 111383,…

  Quantity: 34,180 units

• Z-0085-2026 Class I Ongoing

  PROPONENT SR SL (Model L200)

  Codes / lots: GTIN 00802526559020, Serial numbers: 722605, 722614, 722634, 722647. GTIN 00802526576362, Serial numbers: 464359, 464382, 464387, 464444, 464447, 464457, 464462, 464471, 464505, 464511, 464514, 464517, 464521, 464525, 464527, 464541, 464549, 464552, 464554, 464561, 464576, 708351, 708451, 708466, 708471, 708495, 708513, 708514, 708515, 708516, 708517, 708525, 708529, 708532, 708533, 708536, 708618, 708619, 708620, 708622, 708623, 708624, 708625, 708627, 708630, 708651, 708653, 708654, 708655, 708656, 708658, 708660, 708737, 708751, 708764, 708783, 708816, 708824, 708826, 708857, 708862, 708867, 708868, 708879, 708880, 708885, 708887, 708889, 708894, 708898, 708912, 708920, 708922, 708924, 708929, 708939, 708942, 708944, 708945, 708946, 708947, 708948, 708949, 708952, 708959, 708960, 708967, 708968, 708969, 708976, 708980, 708983, 708997, 709003, 709009, 709011, 709015, 709024, 709025,…

  Quantity: 1380 units

• Z-0086-2026 Class I Ongoing

  PROPONENT DR SL (Model L201)

  Codes / lots: GTIN 00802526559044, Serial Numbers: 760356, 760366, 760367, 760404, 760409, 760412, 760441, 760443, 760500. GTIN 00802526576379, Serial numbers: 767280. GTIN 00802526559051, Serial numbers: 767088, 799586. GTIN 00802526576379, Serial Numbers: 100164, 100165, 100174, 100186, 100243, 100767, 100800, 723990, 724576, 724581, 724583, 724597, 724612, 724614, 724616, 724619, 724620, 724640, 724644, 724645, 724654, 724658, 724663, 724664, 724665, 724666, 724670, 724671, 724698, 724700, 724701, 724703, 724724, 724731, 724732, 724733, 724747, 724752, 724753, 724756, 724765, 724766, 724768, 724770, 724773, 724774, 724781, 724785, 724786, 724797, 724807, 724809, 724810, 724811, 724812, 724813, 724814, 724815, 724816, 724817, 724820, 724823, 724826, 724829, 724833, 724869, 724950, 724958, 724974, 724975, 724977, 724980, 724981, 725647, 725651, 725705, 725711, 725734, 725742, 725749, 725774, 725775,…

  Quantity: 2,426 units

• Z-0087-2026 Class I Ongoing

  Model Number L209 PROPONENT DR (VDD) SL Pacemaker

  Codes / lots: GTIN 00802526559068, Serial Numbers: 100002, 100006, 100007, 100008, 100009, 100010, 100011, 100012, 100013, 100014, 100015, 100017, 100019, 100020, 100021, 100022, 100023, 100025, 100026, 100027, 100028, 100029, 100030, 100031, 100032, 100034, 100035, 100036, 100037, 100038, 100039, 100040, 100041, 100042, 100043, 100044, 100045, 100046, 100047, 100048, 100049, 100050, 100051, 100052, 100053, 100055, 100056, 100057, 100058, 100059, 100060, 100061, 100062, 100063, 100064, 100065, 100066, 100067, 100068, 100069, 100070, 100071, 100072, 100073, 100074, 100075, 100076, 100077, 100078, 100079, 100080, 100081, 100082, 100083, 100084, 100085, 100086, 100087, 100088, 100089, 100090, 100091, 100092, 100093, 100094, 100095, 100096, 100097, 100098, 100099, 100100, 100101, 100102, 100103, 100104, 100105, 100106, 100107, 100108, 100111, 100112, 100113, 100114, 100115, 100116, 100117, 100119,…

  Quantity: 3146 units

• Z-0088-2026 Class I Ongoing

  Model Number L210 PROPONENT SR SL Pacemaker

  Codes / lots: GTIN 00802526559082, Serial Numbers: 100002, 100009, 100010, 100011, 100012, 100014, 100017, 100020, 100021, 100023, 100024, 100026, 100029, 100034, 100037, 100038, 100040, 100041, 100045, 100046, 100047, 100049, 100054, 100057, 100061, 100066, 100068, 100071, 100072, 100073, 100074, 100083, 100085, 100093, 100097, 100100, 100103, 100104, 100109, 100112, 100121, 100122, 100124, 100125, 100135, 100136, 100138, 100140, 100147, 100153, 100156, 100162, 100163, 100165, 100166, 100168, 100170, 100171, 100181, 100197, 100205, 100214, 100222, 100235, 100237, 100268, 100270, 100271, 100272, 100273, 100280, 100281, 100288, 100295, 100302, 100309, 100324, 100328, 100337, 100339, 100354, 100359, 100360, 100363, 100369, 100372, 100377, 100384, 100386, 100387, 100391, 100400, 100403, 100404, 100410, 100411, 100413, 100415, 100421, 100423, 100431, 100432, 100434, 100435, 100438, 100439, 100440,…

  Quantity: 41009 units

• Z-0089-2026 Class I Ongoing

  Model Number L211 PROPONENT DR SL MRI Pacemaker

  Codes / lots: GTIN 00802526559105, Serial Numbers: 296409, 658411. GTIN 00802526576409, Serial Numbers: 431535. GTIN 00802526578038, Serial Numbers: 251896, 375153, 396268. GTIN 00802526559105, Serial Numbers: 100009, 100020, 100022, 100024, 100028, 100030, 100031, 100037, 100038, 100039, 100043, 100046, 100047, 100048, 100049, 100052, 100053, 100058, 100061, 100063, 100066, 100068, 100075, 100077, 100078, 100080, 100083, 100087, 100090, 100091, 100095, 100097, 100098, 100106, 100113, 100122, 100125, 100127, 100130, 100131, 100132, 100133, 100143, 100145, 100156, 100158, 100163, 100166, 100167, 100168, 100170, 100172, 100174, 100175, 100179, 100187, 100188, 100191, 100194, 100198, 100206, 100207, 100209, 100210, 100213, 100217, 100218, 100219, 100220, 100221, 100222, 100223, 100224, 100225, 100226, 100230, 100231, 100237, 100244, 100246, 100247, 100248, 100249, 100268, 100269, 100270, 100271, 100275,…

  Quantity: 106,536 units

• Z-0090-2026 Class I Ongoing

  Model Number L221 PROPONENT DR EL Pacemaker

  Codes / lots: GTIN 00802526578045, Serial Numbers: 723080, 723248, 725570, 729255. GTIN 00802526559129. Serial Numbers: 732639. GTIN 00802526576416, Serial numbers: 100156, 100157, 100167, 100180, 100185, 100247, 100254, 100263, 100268, 100272, 100278, 100279, 100282, 100293, 100296, 100302, 100304, 100305, 100306, 100308, 100314, 100315, 100332, 100335, 100336, 100453, 702524, 702763, 703141, 703183, 703341, 703490, 704875, 705065, 705069, 706965, 707072, 707119, 707355, 707474, 707499, 707999, 708019, 708170, 708229, 709024, 712293, 712330, 712402, 712408, 712424, 712437, 712517, 713937, 714362, 714643, 714710, 714836, 714847, 715761, 715890, 716146, 716435, 716731, 717103, 717117, 717537, 718007, 718062, 718114, 718137, 718139, 718301, 718312, 719571, 719630, 719635, 719637, 719653, 719835, 720752, 720838, 721277, 721298, 721511, 721604, 722560, 723084, 723234, 723279, 723335, 723486, 723491,…

  Quantity: 3592 units

• Z-0091-2026 Class I Ongoing

  Model Number L231, PROPONENT DR EL MRI Pacemaker

  Codes / lots: GTIN 00802526559143, Serial Numbers: 756161, 799038, 841168. GTIN 00802526576423, Serial Numbers: 532638, 880141, 973836. GTIN 00802526578052, Serial Numbers: 594082, 727921, 812172, 832267, 899037, 944246, 978524. GTIN 00802526559143, Serial Numbers: 100008, 100026, 100030, 100038, 100045, 100046, 100052, 100053, 100059, 100061, 100066, 100077, 100078, 100079, 100081, 100083, 100087, 100088, 100099, 100104, 100105, 100108, 100114, 100126, 100130, 100134, 100136, 100142, 100148, 100151, 100153, 100154, 100156, 100161, 100162, 100163, 100164, 100165, 100168, 100172, 100175, 100178, 100180, 100181, 100187, 100188, 100190, 100191, 100193, 100196, 100199, 100201, 100203, 100205, 100206, 100207, 100208, 100210, 100212, 100213, 100216, 100218, 100220, 100235, 100236, 100243, 100244, 100245, 100246, 100247, 100251, 100252, 100253, 100254, 100256, 100261, 100265, 100275, 100279, 100280, 100282,…

  Quantity: 63,851 units

• Z-0092-2026 Class I Ongoing

  Model Number L100, ESSENTIO SR SL Pacemaker

  Codes / lots: GTIN 00802526559150, Serial Numbers: 464853, 464855, 464865, 464866, 464867, 464868, 464871, 464872, 464874, 464879, 464881, 464882, 464886, 464896, 464907, 464911, 464912, 464913, 464914, 464915, 464916, 464917, 464919, 464921, 464922, 464925, 464927, 464929, 464930, 464935, 464937, 464938, 464939, 464940, 464941, 464947, 464948, 464955, 464956, 464957, 464960, 464962, 464966, 464967, 464970, 464971, 464972, 464977, 464978, 464979, 464980, 464982, 464983, 464988, 464991, 464997, 464998, 464999, 465004, 465005, 465006, 465007, 465009, 465011, 465012, 465014, 465015, 465019, 465025, 465026, 465027, 465029, 465032, 465037, 465038, 465041, 465043, 465044, 465046, 465049, 465050, 465053, 465054, 465055, 465056, 465057, 465060, 465061, 465062, 465063, 465064, 465065, 465067, 465069, 465070, 465072, 465075, 465076, 465078, 465079, 465081, 465084, 465085, 465088, 465089, 465092, 465093,…

  Quantity: 4827 units

• Z-0093-2026 Class I Ongoing

  Model Number L101, ESSENTIO DR SL Pacemaker

  Codes / lots: GTIN 00802526559174, Serial Numbers: 100547, 100752, 100822, 100843, 100852, 100853, 100857, 100863, 100865, 100866, 100868, 100871, 100874, 100879, 100883, 100884, 100889, 100891, 100892, 100893, 100897, 100900, 100914, 100915, 100916, 100919, 100923, 100925, 100927, 100928, 100931, 100932, 100938, 100941, 100942, 100944, 100948, 100949, 100952, 100955, 100956, 100957, 100962, 100969, 100970, 100972, 100973, 100980, 100981, 100982, 100985, 100986, 100988, 100989, 100990, 100991, 100993, 100995, 100996, 101000, 101002, 101003, 101004, 101006, 101012, 101014, 101015, 101016, 101017, 101020, 101021, 101022, 101024, 101025, 101033, 101036, 101037, 101042, 101044, 101048, 101050, 101052, 101053, 101059, 101061, 101063, 101067, 101073, 101074, 101075, 101076, 101087, 101090, 101092, 101093, 101096, 101097, 101098, 101105, 101106, 101108, 101109, 101110, 101111, 101113, 101120, 101125,…

  Quantity: 22,714 units

• Z-0094-2026 Class I Ongoing

  Model Number L110, ESSENTIO SR SL MRI Pacemaker

  Codes / lots: GTIN 00802526559204, Serial Numbers: 102163, 700197, 700207, 701035, 701546, 702086, 702129, 702195, 702303, 702316, 702343, 702530, 702612, 702615, 702619, 702715, 702745, 702802, 702807, 702833, 702840, 702844, 702871, 702872, 702890, 702891, 702898, 702912, 702918, 702925, 702930, 702931, 702966, 702974, 702979, 702991, 702999, 703010, 703035, 703047, 703053, 703058, 703065, 703069, 703090, 703099, 703101, 703122, 703124, 703136, 703142, 703147, 703150, 703152, 703173, 703177, 703191, 703199, 703240, 703241, 703247, 703252, 703261, 703297, 703306, 703326, 703339, 703348, 703353, 703376, 703380, 703417, 703420, 703450, 703452, 703453, 703460, 703510, 703511, 703535, 704093, 704200, 704263, 704341, 704480, 704580, 704656, 704661, 704678, 704679, 704703, 704726, 704755, 704769, 704802, 704812, 704813, 704815, 704817, 704820, 704823, 704839, 704849, 704869, 704872, 704875, 704895,…

  Quantity: 61,700 units

• Z-0095-2026 Class I Ongoing

  Model Number L111, ESSENTIO DR SL MRI Pacemaker

  Codes / lots: GTIN 00802526559228, Serial numbers: 103410, 200337, 200359, 200704, 201273, 201585, 202131, 203086, 204240, 204255, 204383, 204472, 204532, 204553, 204558, 204581, 204619, 204644, 204658, 204672, 204680, 204704, 204729, 204735, 204748, 204768, 204779, 204855, 204883, 204891, 204907, 204916, 204929, 204934, 204947, 204951, 204957, 204959, 204968, 204985, 205002, 205044, 205073, 205083, 205105, 205130, 205149, 205192, 205199, 205211, 205227, 205233, 205236, 205290, 205360, 205362, 205363, 205408, 205412, 205413, 205415, 205455, 205480, 205543, 205553, 205560, 205585, 205586, 205587, 205625, 205632, 205636, 205672, 205673, 205686, 205688, 205733, 205742, 205767, 205770, 205773, 205782, 205791, 205796, 205797, 205810, 205854, 205855, 205857, 205861, 205863, 205907, 205911, 205920, 205940, 205945, 205946, 205958, 205961, 205965, 205967, 205971, 205975, 205977, 205979, 205989, 205992,…

  Quantity: 223,163 units

• Z-0096-2026 Class I Ongoing

  Model Number L121 ESSENTIO DR EL Pacemaker

  Codes / lots: GTIN 00802526559242, Serial Numbers: 100009, 100026, 100029, 100030, 100031, 100042, 100189, 100192, 100207, 100290, 100309, 100310, 100311, 100312, 100317, 100320, 100322, 100324, 100328, 100331, 100333, 100334, 100362, 100368, 100375, 100377, 100382, 100383, 100385, 100386, 100394, 100397, 100399, 100400, 100402, 100404, 100406, 100407, 100408, 100410, 100411, 100412, 100413, 100414, 100415, 100417, 100420, 100423, 100424, 100425, 100428, 100429, 100430, 100431, 100433, 100435, 100438, 100440, 100444, 100445, 100448, 100449, 100450, 100454, 100456, 100457, 100458, 100459, 100461, 100462, 100463, 100464, 100466, 100470, 100474, 100480, 100491, 100492, 100495, 100497, 100498, 100500, 100501, 100503, 100506, 100510, 100513, 100515, 100521, 100522, 100525, 100527, 100530, 100534, 100535, 100537, 100538, 100541, 100542, 100554, 100555, 100556, 100558, 100559, 100560, 100561, 100562,…

  Quantity: 10,833 units

• Z-0097-2026 Class I Ongoing

  Model Number L131, ESSENTIO DR EL MRI Pacemaker

  Codes / lots: GTIN 00802526559266, Serial Numbers: 102068, 102071, 102072, 102074, 102086, 102089, 102091, 102092, 102094, 102095, 102097, 102101, 102102, 102104, 102108, 102115, 102120, 102122, 102124, 102129, 102145, 102146, 102149, 102157, 102175, 102176, 102181, 102187, 102188, 102189, 102191, 102194, 102195, 102196, 102197, 102198, 102202, 102203, 102205, 102206, 102207, 102208, 102211, 102212, 102213, 102215, 102218, 102221, 102223, 102226, 102227, 102228, 102235, 102240, 102241, 102244, 102250, 102253, 102258, 102259, 102262, 102268, 102270, 102271, 102275, 102281, 102282, 102283, 102284, 102285, 102286, 102288, 102289, 102294, 102304, 102308, 102310, 102312, 102318, 102319, 102320, 102321, 102322, 102328, 102330, 102331, 102332, 102334, 102336, 102338, 102339, 102341, 102342, 102345, 102348, 102352, 102359, 102360, 102365, 102366, 102369, 102372, 102376, 102377, 102381, 102382, 102383,…

  Quantity: 190,088 units

• Z-0098-2026 Class I Ongoing

  Model Number S701 ALTRUA 2 SR SL Pacemaker

  Codes / lots: GTIN 00802526576492, Serial numbers: 705372. GTIN 00802526559334. Serial numbers: 100002, 100003, 100004, 100005, 100007, 100008, 100009, 100010, 100011, 100012, 100013, 100014, 100015, 100016, 100017, 100018, 100019, 100020, 100021, 100022, 100023, 100025, 100026, 100027, 100028, 100030, 100031, 100032, 100033, 100034, 100035, 100036, 100037, 100038, 100039, 100040, 100041, 100042, 100043, 100044, 100045, 100046, 100047, 100048, 100049, 100050, 100051, 100052, 100053, 100054, 100055, 100056, 100057, 100058, 100059, 100060, 100061, 100062, 100063, 100064, 100065, 100066, 100067, 100068, 100069, 100070, 100071, 100072, 100073, 100075, 100076, 100077, 100078, 100079, 100081, 100082, 100083, 100084, 100085, 100086, 100087, 100088, 100090, 100091, 100092, 100093, 100094, 100095, 100096, 100097, 100098, 100099, 100100, 100101, 100102, 100103, 100104, 100106, 100109, 100111, 100112, 100114,…

  Quantity: 4841 units

• Z-0099-2026 Class I Ongoing

  Model Number S702, ALTRUA 2 DR SL Pacemaker

  Codes / lots: GTIN 00802526559358, Serial numbers: 100002, 100003, 100004, 100005, 100006, 100007, 100008, 100009, 100010, 100011, 100012, 100013, 100014, 100015, 100016, 100017, 100018, 100020, 100021, 100025, 100026, 100028, 100029, 100030, 100031, 100032, 100033, 100034, 100035, 100036, 100037, 100038, 100040, 100042, 100045, 100046, 100050, 100051, 100052, 100053, 100054, 100055, 100056, 100057, 100058, 100059, 100060, 100061, 100062, 100063, 100064, 100065, 100066, 100067, 100068, 100069, 100070, 100071, 100072, 100073, 100074, 100075, 100076, 100077, 100078, 100079, 100080, 100081, 100082, 100083, 100084, 100085, 100086, 100087, 100088, 100089, 100090, 100092, 100093, 100094, 100095, 100096, 100097, 100098, 100099, 100100, 100101, 100102, 100103, 100104, 100105, 100106, 100107, 100108, 100109, 100110, 100112, 100113, 100115, 100116, 100117, 100118, 100119, 100120, 100121, 100122, 100123,…

  Quantity: 4055 units

• Z-0100-2026 Class I Ongoing

  Model Number S722, ALTRUA 2 DR EL Pacemaker

  Codes / lots: GTIN 00802526559372, Serial numbers: 100037, 100039, 100040, 100041, 100042, 100052, 100066, 100067, 100068, 100070, 100071, 100072, 100073, 100075, 100076, 100077, 100080, 100081, 700442, 700445, 700447, 700448, 700452, 700455, 700470, 700486, 700541, 700554, 700568, 700569, 700589, 700636, 700666, 702537, 702548, 702681, 702731, 702760, 702763, 702766, 702767, 702773, 702775, 702900, 702902, 702903, 702911, 702930, 704458, 704459, 704521, 707526, 707529, 708164, 708180, 708183, 708252, 708264, 708427. GTIN 00802526576515, Serial numbers: 100002, 100003, 100004, 100006, 100008, 100009, 100010, 100011, 100012, 100014, 100015, 100016, 100017, 100018, 100019, 100020, 100021, 100022, 100023, 100024, 100025, 100026, 100027, 100029, 100030, 100031, 100032, 100033, 100034, 100035, 100036, 100038, 100044, 100046, 100047, 100048, 100049, 100050, 100053, 100054, 100055, 100056, 100057, 100059,…

  Quantity: 3376 units

• Z-0101-2026 Class I Ongoing

  Model Number U125, VALITUDE CRT-P EL

  Codes / lots: GTIN 00802526559389, Serial numbers: 100095, 100182, 100194, 100221, 100236, 100239, 100242, 100243, 100247, 100254, 100258, 100259, 100263, 100270, 100285, 100287, 100292, 100298, 100301, 100302, 100307, 100310, 100315, 100323, 100331, 100333, 100339, 100342, 100343, 100348, 100349, 100350, 100357, 100358, 100359, 100360, 100362, 100366, 100367, 100371, 100372, 100375, 100378, 100386, 100390, 100392, 100394, 100396, 100397, 100401, 100402, 100403, 100406, 100409, 100412, 100413, 100418, 100419, 100420, 100423, 100429, 100430, 100432, 100435, 100438, 100448, 100452, 100453, 100455, 100456, 100458, 100462, 100466, 100467, 100472, 100473, 100475, 100476, 100480, 100481, 100482, 100485, 100486, 100489, 100492, 100493, 100495, 100496, 100497, 100498, 100499, 100500, 100502, 100505, 100510, 100514, 100518, 100526, 100529, 100532, 100533, 100536, 100537, 100539, 100540, 100541, 100544,…

  Quantity: 3620 units

• Z-0102-2026 Class I Ongoing

  Model Number U128, VALITUDE CRT-P EL MRI

  Codes / lots: GTIN 00802526559402, Serial numbers: 100187, 100217, 100222, 100236, 100251, 100253, 100260, 100262, 100274, 100275, 100277, 100289, 100317, 100328, 100330, 100350, 100359, 100361, 100363, 100364, 100369, 100372, 100373, 100376, 100379, 100381, 100386, 100391, 100392, 100394, 100397, 100399, 100400, 100401, 100402, 100404, 100410, 100411, 100414, 100417, 100420, 100433, 100435, 100437, 100444, 100445, 100447, 100449, 100450, 100452, 100453, 100456, 100458, 100459, 100463, 100466, 100471, 100473, 100474, 100475, 100476, 100481, 100482, 100483, 100484, 100485, 100486, 100491, 100497, 100500, 100501, 100502, 100503, 100506, 100507, 100511, 100513, 100514, 100519, 100520, 100522, 100523, 100527, 100533, 100535, 100536, 100537, 100539, 100541, 100544, 100545, 100547, 100550, 100551, 100553, 100556, 100557, 100560, 100562, 100563, 100564, 100565, 100569, 100570, 100571, 100572, 100573,…

  Quantity: 28,911 units

• Z-0103-2026 Class I Ongoing

  Model Number U225 VISIONIST CRT-P EL

  Codes / lots: GTIN 00802526559426, Serial numbers: 709683, 709711, 709737, 709778, 709780, 709789, 709792, 709794, 709804, 709815, 709816, 709827, 709828, 709829, 709830, 709831, 709889, 709907, 709912, 709914, 709926, 709935, 709938, 709941, 709943, 709962, 709965, 709966, 709969, 709985, 710005, 710016, 710027, 710105, 710235, 710283, 710379, 710386, 710408, 710414, 710416, 710418, 710424, 710438, 710443, 710450, 710458, 710459, 710466, 710467, 710479, 710481, 710482, 710490, 710540, 710544, 710545, 710558, 710561, 710566, 710571, 710572, 710575, 710586, 710593, 710595, 710600, 710613, 710622, 710624, 711100, 711103, 711115, 711116, 711186, 711234, 711261, 711493, 711497, 711646, 711698, 711699, 711704, 711706, 711719, 711756, 711771, 711780, 711781, 711783, 711784, 711812, 711817, 711852, 711859, 711865, 711867, 711870, 711881, 711894, 711896, 711901, 711913, 711915, 711916, 711927, 711929,…

  Quantity: 12,326 units

• Z-0104-2026 Class I Ongoing

  Model Number U226, VISIONIST CRT-P EL

  Codes / lots: GTIN 00802526559457, Serial numbers: 700333, 700335, 700342, 700344, 700346, 700347, 700352, 700364, 700372, 700386, 700388, 700390, 700391, 700425, 700426, 700427, 700428, 700429, 700437, 700448, 700455, 700460, 700461, 700464, 700490, 700498, 700500, 700520, 700538, 700539, 700570, 700587, 700591, 700638, 700653, 700665, 700676, 700693, 700700, 700702, 700704, 700705, 700707, 700708, 700711, 700718, 700720, 700722, 700735, 700736, 700755, 700759, 700765, 700768, 700774, 700782, 700790, 700794, 700796, 700809, 700817, 700830, 700870, 700874, 700879, 700881, 700882, 700883, 700887, 700889, 700903, 700905, 700908, 700911, 700917, 700925, 700935, 700940, 700950, 700951, 700959, 700968, 700970, 700978, 700980, 700984, 700988, 700990, 700991, 700994, 700997, 701005, 701008, 701017, 701019, 701023, 701032, 701038, 701048, 701071, 701083, 701091, 701096, 701097, 701100, 701108, 701116,…

  Quantity: 1,050 units

• Z-0105-2026 Class I Ongoing

  Model Number U228, VISIONIST CRT-P EL MRI

  Codes / lots: GTIN 00802526559471, Serial numbers: 726570, 728246, 728341, 728391, 728414, 728416, 728463, 728492, 728880, 732912, 733290, 733427, 733464, 733475, 733541, 733672, 733700, 733703, 733748, 733749, 733755, 733756, 733773, 733776, 733778, 733791, 733792, 733794, 733797, 733799, 733800, 733801, 733804, 733805, 733807, 733808, 733811, 733812, 733815, 733818, 733819, 733820, 733824, 733829, 733830, 733832, 733833, 733834, 733841, 733842, 733843, 733846, 733851, 733852, 733853, 733854, 733859, 733861, 733862, 733864, 733876, 733880, 733881, 733883, 733887, 733888, 733895, 733896, 733897, 733898, 733899, 733904, 733907, 733908, 733909, 733916, 733925, 733926, 733927, 733928, 733931, 733934, 733935, 733936, 733939, 733944, 733960, 733976, 733980, 733982, 734809, 734811, 734812, 734822, 734824, 734837, 734844, 734870, 734880, 734884, 734899, 734902, 734939, 734944, 734955, 734960, 734967,…

  Quantity: 41,191 units