Z-0100-2026Class I
Model Number S722, ALTRUA 2 DR EL Pacemaker
Boston Scientific Corporation / initiated 2025-08-20 / Open, Classified / root cause: software
Boston Scientific Corporation began a recall of Model Number S722, ALTRUA 2 DR EL Pacemaker on . FDA classified it as Class I and gives the reason as "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...". As of , the recall status on record is Open, Classified, and MDM tags the root cause as software.
Recall record
- Recall number
- Z-0100-2026
- Classification
- Class I
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Boston Scientific Corporation
- Product
- Model Number S722, ALTRUA 2 DR EL Pacemaker
- Product code
- LWP Implantable Pulse Generator, Pacemaker (Non-Crt)
- 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).
- Root cause tag
- software
- FDA root cause
- Other
- Action
- Boston Scientific issued an "Urgent Medical Device Correction" notice to its customers on 08/18/2025 via letter. The notice provides an update to the December 2024 customer communication regarding the potential for the ACCOLADE family of pacemakers to initiate Safety Mode due to a high battery impedance state and contains recommendations timely upgrade of pacemaker software to prevent the occurrence of Safety Mode in an ambulatory setting. On 09/05/2025 an update to the 08/18/2025 notice (via letter), superseding the prior notice to address two unintended behaviors associated with the Model 3869 v2.04 software (designed to prevent potential initiation of Safety Mode due to a high battery impedance condition). The behaviors are: 1. Incomplete disablement of wandless automatic telemetry after detecting a high battery impedance condition. If an ACCOLADE family device with an elevated battery impedance induced Code-1003 remains in service, the software s new telemetry activated battery test is designed to continue assessing battery impedance and disable all wandless telemetry operation before high impedance is achieved and device resets can initiate Safety Mode. 2. Potential for the software s new daily battery test to misinterpret measurements in the presence of a magnet, initiating a false positive response that results in disablement of wandless telemetry sessions. For patients monitored via LATITUDE, this will trigger an alert message indicating an erroneous explant indicator (e.g., explant indicator was reached January 1, 2000) if the device had not previously reached replacement indication, stating that LATITUDE is no longer available, and prompting to contact Technical Services. Patients were notified regarding battery performance. Advisory is published at www.BostonScientific.com/advisory. If you have any questions, contact US Technical Services at 1.800.CARDIAC (227.3422) or email to: [email protected].
- Quantity in commerce
- 3376 units
- Distribution
- Worldwide
- Product codes and 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, 100060, 100061, 100064, 100078, 100082, 100083, 100084, 100086, 100088, 100089, 100090, 100091, 100092, 100093, 100094, 100095, 100096, 700001, 700002, 700003, 700004, 700005, 700006, 700007, 700008, 700009, 700011, 700012, 700013, 700014, 700016, 700017, 700018, 700019, 700020, 700031, 700032, 700033, 700034, 700035, 700036, 700037, 700039, 700040, 700041, 700042, 700043, 700044, 700045, 700046, 700047, 700048, 700049, 700050, 700052, 700053, 700054, 700055, 700056, 700057, 700058, 700059, 700060, 700061, 700062, 700063, 700064, 700065, 700066, 700067, 700068, 700069, 700070, 700071, 700072, 700073, 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707007, 707008, 707009, 707010, 707011, 707012, 707013, 707014, 707015, 707016, 707017, 707018, 707019, 707020, 707021, 707022, 707023, 707024, 707025, 707026, 707027, 707028, 707029, 707030, 707031, 707032, 707033, 707034, 707035, 707037, 707038, 707039, 707040, 707041, 707042, 707043, 707044, 707046, 707048, 707049, 707051, 707052, 707053, 707054, 707056, 707057, 707059, 707060, 707061, 707062, 707063, 707065, 707066, 707070, 707072, 707074, 707076, 707077, 707079, 707080, 707081, 707082, 707084, 707085, 707087, 707088, 707089, 707090, 707091, 707092, 707093, 707094, 707095, 707096, 707097, 707098, 707099, 707100, 707101, 707102, 707103, 707104, 707107, 707111, 707112, 707114, 707115, 707116, 707117, 707118, 707119, 707120, 707121, 707122, 707123, 707124, 707125, 707126, 707127, 707128, 707129, 707130, 707131, 707132, 707133, 707134, 707135, 707136, 707137, 707138, 707139, 707140, 707141, 707142, 707143, 707144, 707145, 707146, 707147, 707148, 707149, 707150, 707151, 707152, 707153, 707154, 707155, 707156, 707157, 707158, 707159, 707160, 707161, 707162, 707163, 707164, 707165, 707166, 707167, 707168, 707169, 707170, 707171, 707172, 707173, 707174, 707175, 707176, 707177, 707178, 707179, 707180, 707181, 707182, 707183, 707184, 707185, 707186, 707187, 707188, 707189, 707190, 707191, 707192, 707193, 707194, 707195, 707196, 707197, 707198, 707199, 707200, 707201, 707202, 707203, 707204, 707205, 707206, 707207, 707208, 707209, 707210, 707211, 707212, 707213, 707214, 707215, 707216, 707217, 707218, 707219, 707220, 707221, 707222, 707223, 707224, 707225, 707226, 707227, 707228, 707229, 707230, 707231, 707232, 707233, 707234, 707235, 707236, 707237, 707238, 707240, 707241, 707243, 707245, 707247, 707248, 707249, 707250, 707251, 707252, 707253, 707254, 707255, 707256, 707257, 707258, 707259, 707260, 707261, 707262, 707263, 707264, 707265, 707267, 707268, 707269, 707270, 707271, 707272, 707273, 707274, 707275, 707276, 707277, 707278, 707279, 707280, 707281, 707282, 707283, 707284, 707285, 707286, 707287, 707288, 707289, 707290, 707291, 707292, 707293, 707294, 707295, 707296, 707297, 707298, 707299, 707300, 707301, 707302, 707303, 707304, 707305, 707306, 707307, 707309, 707310, 707311, 707312, 707313, 707314, 707315, 707316, 707317, 707318, 707319, 707320, 707321, 707322, 707323, 707324, 707325, 707326, 707327, 707328, 707329, 707330, 707332, 707333, 707334, 707335, 707336, 707338, 707339, 707340, 707341, 707342, 707343, 707344, 707345, 707347, 707348, 707349, 707350, 707351, 707352, 707353, 707354, 707355, 707356, 707357, 707358, 707359, 707360, 707361, 707362, 707363, 707364, 707365, 707366, 707367, 707368, 707369, 707370, 707371, 707372, 707373, 707374, 707375, 707376, 707377, 707378, 707379, 707380, 707382, 707383, 707384, 707385, 707386, 707387, 707388, 707389, 707390, 707391, 707392, 707393, 707394, 707395, 707396, 707397, 707398, 707399, 707400, 707401, 707402, 707403, 707404, 707405, 707406, 707407, 707408, 707409, 707410, 707411, 707412, 707413, 707422, 707427, 707434, 707435, 707436, 707438, 707439, 707440, 707441, 707443, 707444, 707445, 707446, 707447, 707448, 707449, 707450, 707451, 707452, 707453, 707456, 707459, 707461, 707478, 707480, 707481, 707483, 707485, 707489, 707494, 707500, 707502, 707503, 707504, 707505, 707514, 707517, 707518, 707519, 707520, 707523, 707524, 707525, 707531, 707535, 707536, 707540, 707541, 707544, 707546, 707547, 707548, 707549, 707550, 707551, 707553, 707556, 707557, 707560, 707561, 707562, 707564, 707566, 707569, 707570, 707571, 707573, 707574, 707575, 707579, 707582, 707583, 707584, 707585, 707586, 707587, 707588, 707591, 707592, 707593, 707595, 707597, 707598, 707599, 707601, 707602, 707606, 707607, 707608, 707609, 707611, 707613, 707617, 707620, 707623, 707625, 707627, 707630, 707632, 707635, 707637, 707639, 707640, 707642, 707643, 707644, 707647, 707651, 707652, 707653, 707654, 707656, 707657, 707660, 707661, 707662, 707663, 707664, 707665, 707666, 707668, 707669, 707670, 707671, 707674, 707676, 707677, 707678, 707679, 707680, 707681, 707682, 707684, 707685, 707687, 707688, 707689, 707692, 707693, 707694, 707695, 707696, 707697, 707698, 707699, 707700, 707701, 707702, 707703, 707704, 707705, 707706, 707707, 707708, 707709, 707710, 707711, 707713, 707714, 707716, 707717, 707718, 707719, 707720, 707721, 707723, 707725, 707726, 707727, 707728, 707729, 707730, 707732, 707734, 707735, 707736, 707737, 707738, 707740, 707741, 707743, 707744, 707747, 707748, 707749, 707750, 707751, 707752, 707753, 707754, 707755, 707758, 707759, 707760, 707761, 707763, 707764, 707765, 707766, 707768, 707769, 707770, 707771, 707772, 707773, 707774, 707775, 707776, 707777, 707778, 707780, 707783, 707784, 707785, 707786, 707787, 707791, 707792, 707794, 707795, 707798, 707800, 707801, 707803, 707804, 707805, 707806, 707807, 707808, 707809, 707810, 707811, 707812, 707813, 707814, 707815, 707817, 707819, 707821, 707822, 707823, 707825, 707826, 707828, 707829, 707830, 707833, 707834, 707838, 707840, 707843, 707844, 707845, 707846, 707848, 707849, 707850, 707852, 707860, 707861, 707865, 707867, 707876, 707877, 707878, 707880, 707881, 707883, 707886, 707891, 707892, 707893, 707898, 707899, 707904, 707908, 707912, 707915, 707918, 707919, 707920, 707921, 707922, 707923, 707925, 707927, 707928, 707929, 707931, 707936, 707937, 707940, 707942, 707943, 707945, 707954, 707957, 707960, 707961, 707966, 707968, 707969, 707970, 707971, 707975, 707976, 707978, 707979, 707980, 707981, 707987, 707988, 707990, 707991, 707994, 707995, 708001, 708005, 708006, 708010, 708011, 708012, 708013, 708016, 708020, 708023, 708024, 708025, 708026, 708031, 708032, 708033, 708035, 708036, 708037, 708038, 708039, 708041, 708042, 708046, 708047, 708050, 708056, 708057, 708059, 708060, 708061, 708064, 708066, 708068, 708069, 708071, 708072, 708074, 708076, 708079, 708081, 708083, 708085, 708086, 708087, 708090, 708095, 708097, 708098, 708099, 708100, 708102, 708103, 708106, 708107, 708108, 708109, 708112, 708113, 708116, 708119, 708120, 708122, 708123, 708124, 708126, 708128, 708129, 708130, 708131, 708132, 708133, 708134, 708135, 708140, 708141, 708142, 708143, 708144, 708145, 708147, 708148, 708149, 708150, 708151, 708152, 708153, 708154, 708155, 708156, 708157, 708158, 708160, 708162, 708165, 708166, 708167, 708169, 708170, 708171, 708172, 708174, 708175, 708178, 708181, 708182, 708187, 708194, 708195, 708196, 708197, 708198, 708199, 708200, 708201, 708202, 708203, 708205, 708206, 708208, 708210, 708212, 708213, 708214, 708216, 708217, 708218, 708221, 708222, 708223, 708225, 708226, 708227, 708228, 708229, 708232, 708233, 708234, 708236, 708237, 708238, 708239, 708240, 708242, 708244, 708245, 708246, 708247, 708248, 708251, 708253, 708255, 708256, 708257, 708258, 708259, 708261, 708262, 708263, 708266, 708268, 708270, 708275, 708276, 708278, 708279, 708281, 708282, 708283, 708285, 708287, 708290, 708291, 708292, 708296, 708298, 708299, 708300, 708301, 708302, 708303, 708304, 708305, 708306, 708309, 708310, 708312, 708314, 708315, 708317, 708318, 708319, 708321, 708330, 708339, 708349, 708351, 708365, 708381, 708384, 708386, 708388, 708392, 708394, 708395, 708396, 708397, 708400, 708401, 708402, 708403, 708404, 708405, 708406, 708407, 708408, 708409, 708410, 708411, 708412, 708414, 708416, 708419, 708420, 708422, 708424, 708425, 708426, 708428, 708429, 708430, 708431, 708433, 708439, 708444, 708445, 708446, 708447, 708448, 708449, 708450, 708451, 708452, 708453, 708454, 708455, 708456, 708457, 708458, 708460, 708461, 708463, 708464, 708465, 708466, 708467, 708468, 708469, 708470, 708471, 708472, 708473, 708494, 708496, 708498, 708499, 708500, 708502, 708503, 708504, 708505, 708507, 708510, 708514, 708515, 708516, 708517, 708521, 708523, 708524, 708528, 708530, 708534, 708535, 708536, 708537, 708538, 708539, 708540, 708541, 708542, 708543, 708544, 708545, 708546, 708547, 708548, 708549, 708550, 708551, 708552, 708553, 708554, 708555, 708556, 708557, 708558, 708559, 708560, 708561, 708562, 708563, 708564, 708565, 708566, 708567, 708568, 708569, 708570, 708571, 708572, 708573, 708574, 708575, 708576, 708577, 708578, 708579, 708580, 708581, 708583, 708584, 708585, 708586, 708587, 708588, 708590, 708591, 708592, 708600, 708604, 708605, 708606, 708607, 708608, 708610, 708611, 708612, 708618, 708621, 708624, 708628, 708630, 708632, 708633, 708634, 708641, 708643, 708644, 708645, 708653, 708658, 708659, 708661, 708675, 708696, 708699, 708700, 708706, 708708, 708712, 708721, 708722, 708728, 708729, 708734, 708735, 708739, 708742, 708743, 708760, 708764, 708772, 708794, 708796, 708804, 708807, 708808, 708809, 708810, 708813, 708814, 708816, 708817, 708818, 708819, 708822, 708826, 708828, 708829, 708830, 708832, 708833, 708836, 708838, 708844, 708845, 708846, 708847, 708848, 708849, 708850, 708851, 708852, 708853. GTIN 00802526578113, Serial numbers: 700133, 700155, 700201, 700207, 700210, 700211, 700216, 700226, 700229, 700236, 700238, 700240, 700246, 700255, 700258, 700278, 700281, 700286, 700287, 700300, 700311, 700317, 700320, 700323, 700324, 700325, 700326, 700327, 700328, 700329, 700330, 700331, 700332, 700333, 700334, 700335, 700411, 700414, 700415, 700417, 700421, 700422, 700423, 700424, 700425, 700427, 700429, 700432, 700433, 700435, 700438, 700440, 700444, 700449, 700451, 700456, 700467, 700468, 700483, 700484, 700493, 700508, 700538, 700549, 700622, 700661, 700664, 700679, 700721, 700724, 700731, 700781, 700782, 700789, 700793, 700799, 700806, 700810, 700816, 700825, 700830, 700835, 700841, 700844, 700853, 700856, 700857, 700880, 701041, 701046, 701079, 701082, 701103, 701109, 701115, 701118, 701119, 701121, 701124, 701129, 701131, 701133, 701134, 701136, 701139, 701140, 701141, 701142, 701146, 701148, 701151, 701154, 701158, 701159, 701162, 701164, 701165, 701169, 701170, 701171, 701175, 701176, 701178, 701183, 701195, 701205, 701214, 701215, 701222, 701234, 701238, 701241, 701246, 701249, 701250, 701252, 701253, 701254, 701256, 701258, 701262, 701264, 701266, 701268, 701269, 701270, 701271, 701273, 701275, 701279, 701280, 701287, 701290, 701292, 701296, 701300, 701312, 701313, 701314, 701315, 701316, 701317, 701318, 701319, 701321, 701326, 701327, 701329, 701330, 701331, 701333, 701335, 701336, 701337, 701338, 701341, 701342, 701343, 701344, 701345, 701346, 701347, 701348, 701349, 701350, 701351, 701352, 701353, 701354, 701355, 701356, 701357, 701358, 701359, 701360, 701361, 701362, 701363, 701364, 701365, 701366, 701367, 701368, 701369, 701370, 701371, 701372, 701373, 701374, 701375, 701376, 701377, 701378, 701379, 701380, 701381, 701439, 701449, 701455, 701463, 701492, 701499, 701507, 701510, 701524, 701533, 701534, 701535, 701536, 701537, 701538, 701539, 701540, 701541, 701545, 701546, 701548, 701550, 701552, 701553, 701555, 701556, 701557, 701559, 701562, 701563, 701565, 701566, 701567, 701568, 701569, 701570, 701573, 701574, 701576, 701577, 701578, 701581, 701684, 701687, 701691, 701695, 701701, 701720, 701721, 701730, 701734, 701740, 701742, 701744, 701748, 701749, 701756, 701759, 701762, 701763, 701765, 701771, 701772, 701773, 701774, 701775, 701776, 701779, 701782, 701783, 701785, 701786, 701787, 701789, 701791, 701792, 701794, 701795, 701796, 701797, 701798, 701799, 701800, 701802, 701803, 701807, 701811, 701812, 701815, 701816, 701820, 701821, 701846, 701869, 701880, 702043, 702044, 702045, 702053, 702062, 702065, 702066, 702076, 702084, 702086, 702087, 702093, 702094, 702100, 702109, 702112, 702113, 702117, 702119, 702126, 702128, 702141, 702145, 702147, 702149, 702163, 702180, 702184, 702185, 702189.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0079-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-0080-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-0081-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-0082-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-0083-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-0084-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-0085-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-0086-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-0087-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-0088-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-0089-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-0090-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-0091-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-0092-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-0093-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-0094-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-0095-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-0096-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-0097-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-0098-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-0099-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-0100-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-0101-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-0102-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-0103-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-0104-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-0105-2026 | Class I | Ongoing | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.