--- title: "ACCOLADE DR EL (Model L321) — FDA record Z-0083-2026 | Is It on Recall" description: "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" url: https://isitonrecall.com/recall/fda-device-z-0083-2026-accolade-dr-el-model-l321/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # ACCOLADE DR EL (Model L321) — FDA record Z-0083-2026 Reported ongoing Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice. Source date Aug 20, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **Product**: ACCOLADE DR EL (Model L321) - **Reason**: 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). - **Classification**: Class I - **Recalling firm**: Boston Scientific Corporation - **Quantity**: 7,488 units - **Agency-reported status**: Ongoing - **Source record identifier**: Z-0083-2026 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0083-2026%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | 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, 100291, 100294, 100295, 100299, 100300, 100337, 100339, 100341, 100344, 100348, 100350, 100351, 100353, 100354, 100355, 100357, 100363, 100366, 100367, 100369, 100371, 100374, 100376, 100378, 100380, 100381, 100384, 100387, 100390, 100395, 100447, 100471, 100482, 100485, 100486, 100496, 100502, 100504, 100509, 100512, 100516, 100518, 100519, 100528, 100532, 100540, 100544, 100547, 100552, 100565, 100572, 100573, 100575, 100577, 100578, 100581, 100583, 100585, 100589, 100592, 100597, 100601, 100603, 100610, 100614, 100741, 100748, 100755, 100761, 100762, 100766, 100771, 100774, 100790, 100791, 100798, 100800, 100802, 100804, 100805, 100809, 100810, 100811, 100816, 100820, 100832, 100835, 100836, 100837, 100849, 100851, 100856, 100858, 100861, 100867, 100869, 100877, 100879, 100883, 100885, 100886, 100891, 100895, 100897, 100899, 100900, 100903, 100904, 100906, 100908, 100909, 100913, 100915, 700014, 700024, 700025, 700026, 700035, 700036, 700037, 700042, 700060, 700079, 700105, 700111, 700123, 700130, 700141, 700142, 700143, 700144, 700162, 700165, 700167, 700172, 700176, 700179, 700185, 700209, 700292, 700340, 700362, 700375, 700405, 700406, 700430, 700436, 700479, 700496, 700545, 700555, 700586, 700588, 700608, 700618, 700677, 700678, 700681, 700715, 700719, 700727, 700730, 700750, 700755, 700762, 700767, 700770, 700773, 700774, 700775, 700778, 700779, 700781, 700792, 700793, 700830, 700835, 700841, 700844, 700862, 700882, 700892, 700895, 700897, 700914, 700924, 700941, 700945, 700946, 700948, 700974, 700979, 700981, 700983, 700984, 700985, 700988, 700992, 700996, 701002, 701004, 701036, 701042, 701046, 701047, 701050, 701051, 701056, 701057, 701069, 701082, 701102, 701105, 701107, 701108, 701110, 701113, 701119, 701120, 701122, 701125, 701126, 701131, 701134, 701135, 701139, 701148, 701149, 701155, 701156, 701157, 701166, 701174, 701175, 701176, 701178, 701185, 701186, 701187, 701188, 701190, 701192, 701193, 701206, 701223, 701226, 701235, 701236, 701238, 701239, 701244, 701245, 701247, 701248, 701251, 701256, 701259, 701265, 701272, 701280, 701283, 701284, 701287, 701292, 701293, 701295, 701296, 701302, 701304, 701322, 701326, 701330, 701334, 701335, 701336, 701343, 701345, 701347, 701348, 701349, 701361, 701362, 701366, 701367, 701368, 701372, 701376, 701380, 701383, 701395, 701412, 701432, 701461, 701484, 701485, 701487, 701490, 701523, 701524, 701528, 701530, 701532, 701533, 701534, 701537, 701538, 701541, 701542, 701547, 701553, 701577, 701578, 701583, 701584, 701607, 701609, 701618, 701641, 701661, 701662, 701665, 701669, 701692, 701704, 701707, 701708, 701744, 701751, 701773, 701778, 701784, 701788, 701793, 701797, 701809, 701810, 701829, 701836, 701837, 701842, 701850, 701861, 701871, 701872, 701883, 701897, 701901, 701903, 701906, 701910, 701912, 701920, 701925, 701927, 701931, 701940, 701941, 701943, 701948, 701949, 701954, 701955, 701956, 701962, 701967, 701970, 701971, 701991, 701995, 701996, 701998, 701999, 702003, 702014, 702015, 702020, 702021, 702026, 702031, 702033, 702049, 702063, 702067, 702070, 702071, 702077, 702084, 702170, 702177, 702195, 702203, 702215, 702224, 702235, 702241, 702242, 702246, 702247, 702248, 702258, 702270, 702290, 702293, 702294, 702316, 702348, 702420, 702424, 702455, 702460, 702463, 702468, 702469, 702482, 702490, 702505, 702520, 702521, 702523, 702525, 702527, 702537, 702548, 702550, 702555, 702558, 702563, 702570, 702572, 702573, 702576, 702585, 702586, 702587, 702597, 702602, 702604, 702605, 702612, 702621, 702623, 702624, 702630, 702635, 702637, 702653, 702656, 702666, 702674, 702682, 702699, 702774, 702799, 702817, 702831, 702839, 702846, 702852, 702854, 702857, 702862, 702875, 702888, 702890, 702915, 702918, 702926, 702936, 702938, 702940, 702951, 702953, 702955, 702962, 702972, 702973, 702979, 702999, 703016, 703027, 703043, 703045, 703046, 703048, 703067, 703068, 703090, 703113, 703116, 703126, 703136, 703147, 703150, 703162, 703166, 703168, 703171, 703174, 703175, 703176, 703201, 703202, 703213, 703219, 703227, 703233, 703237, 703240, 703245, 703247, 703254, 703264, 703276, 703286, 703290, 703305, 703306, 703318, 703333, 703343, 703349, 703352, 703356, 703369, 703370, 703375, 703385, 703386, 703388, 703390, 703397, 703407, 703415, 703443, 703444, 703453, 703459, 703460, 703465, 703466, 703476, 703478, 703491, 703492, 703494, 703502, 703503, 703508, 703539, 703542, 703547, 703564, 703573, 703579, 703582, 703587, 703590, 703599, 703604, 703607, 703611, 703623, 703632, 703634, 703639, 703646, 703648, 703660, 703663, 703666, 703668, 703670, 703677, 703690, 703694, 703696, 703697, 703717, 703719, 703724, 703727, 703737, 703743, 703750, 703751, 703764, 703773, 703777, 703783, 703786, 703788, 703796, 703805, 703830, 703836, 703838, 703841, 703843, 703851, 703864, 703870, 703873, 703888, 703895, 703896, 703898, 703906, 703907, 703909, 703911, 703912, 703915, 703916, 703921, 703924, 703925, 703927, 703928, 703930, 703933, 703935, 703937, 703946, 703947, 703953, 703954, 703955, 703956, 703959, 703960, 703961, 703962, 703963, 703965, 703968, 703969, 703972, 703973, 703977, 703980, 704069, 704117, 704146, 704181, 704185, 704191, 704196, 704201, 704203, 704214, 704215, 704216, 704219, 704220, 704222, 704226, 704231, 704234, 704237, 704238, 704240, 704243, 704244, 704248, 704249, 704250, 704254, 704256, 704258, 704261, 704263, 704265, 704268, 704269, 704272, 704273, 704279, 704287, 704296, 704302, 704304, 704305, 704306, 704315, 704321, 704327, 704344, 704345, 704348, 704349, 704354, 704358, 704360, 704363, 704371, 704374, 704377, 704381, 704383, 704391, 704392, 704403, 704406, 704410, 704414, 704415, 704418, 704419, 704420, 704421, 704440, 704446, 704447, 704450, 704451, 704491, 704527, 704544, 704559, 704579, 704625, 704642, 704669, 704678, 704705, 704723, 704730, 704736, 704738, 704742, 704749, 704750, 704835, 704877, 704880, 704885, 704915, 704919, 704923, 704952, 704985, 705005, 705010, 705015, 705016, 705024, 705034, 705036, 705040, 705041, 705055, 705066, 705067, 705068, 705075, 705076, 705094, 705097, 705100, 705105, 705107, 705121, 705124, 705128, 705129, 705132, 705134, 705157, 705158, 705177, 705206, 705210, 705212, 705241, 705242, 705243, 705248, 705250, 705262, 705283, 705286, 705288, 705315, 705318, 705321, 705368, 705369, 705462, 705536, 705543, 705561, 705620, 705628, 705629, 705634, 705641, 705645, 705646, 705660, 705671, 705672, 705693, 705701, 705708, 705711, 705721, 705726, 705727, 705732, 705735, 705741, 705752, 705761, 705773, 705775, 705776, 705777, 705779, 705786, 705790, 705793, 705794, 705802, 705811, 705822, 705825, 705827, 705838, 705841, 705845, 705850, 705852, 705856, 705857, 705864, 705866, 705870, 705873, 705883, 705884, 705886, 705890, 705900, 705901, 705906, 705913, 705916, 705917, 705918, 705924, 705928, 705932, 705933, 705934, 705938, 705939, 705944, 705946, 705952, 705961, 705962, 705965, 705966, 705972, 705973, 705979, 705981, 705987, 705991, 705993, 705997, 706008, 706011, 706016, 706017, 706018, 706022, 706026, 706027, 706029, 706030, 706032, 706034, 706042, 706043, 706045, 706053, 706054, 706056, 706057, 706060, 706061, 706062, 706063, 706064, 706065, 706066, 706068, 706071, 706078, 706082, 706089, 706090, 706093, 706094, 706095, 706097, 706100, 706101, 706102, 706105, 706107, 706111, 706112, 706113, 706114, 706116, 706117, 706122, 706125, 706126, 706127, 706132, 706134, 706135, 706137, 706138, 706139, 706143, 706144, 706145, 706146, 706154, 706157, 706162, 706164, 706169, 706182, 706203, 706216, 706222, 706224, 706239, 706241, 706242, 706245, 706246, 706249, 706279, 706281, 706289, 706293, 706302, 706305, 706328, 706335, 706348, 706366, 706369, 706370, 706375, 706393, 706395, 706458, 706467, 706487, 706521, 706547, 706550, 706573, 706600, 706607, 706608, 706611, 706618, 706625, 706646, 706649, 706671, 706674, 706698, 706701, 706719, 706722, 706729, 706741, 706750, 706752, 706783, 706785, 706786, 706787, 706788, 706791, 706795, 706804, 706809, 706827, 706829, 706831, 706832, 706834, 706844, 706853, 706867, 706870, 706882, 706889, 706893, 706904, 706914, 706915, 706930, 706938, 706940, 706960, 706993, 707000, 707001, 707017, 707018, 707020, 707046, 707052, 707056, 707066, 707083, 707104, 707106, 707125, 707140, 707142, 707157, 707177, 707187, 707189, 707206, 707209, 707210, 707212, 707215, 707233, 707241, 707244, 707257, 707262, 707267, 707270, 707273, 707289, 707295, 707296, 707311, 707316, 707321, 707322, 707344, 707350, 707360, 707363, 707367, 707368, 707369, 707371, 707385, 707394, 707402, 707413, 707427, 707446, 707465, 707467, 707478, 707482, 707483, 707485, 707497, 707520, 707521, 707526, 707527, 707545, 707562, 707671, 707764, 707822, 707823, 707824, 707825, 707829, 707832, 707856, 707864, 707872, 707899, 707902, 707904, 707912, 707922, 707929, 707934, 707935, 707937, 707939, 707940, 707945, 707951, 707961, 707964, 707966, 707968, 707971, 707973, 707975, 707979, 707980, 707983, 707984, 708003, 708005, 708010, 708012, 708016, 708022, 708024, 708027, 708029, 708047, 708055, 708057, 708060, 708064, 708072, 708074, 708076, 708079, 708088, 708112, 708116, 708122, 708147, 708158, 708168, 708171, 708174, 708182, 708189, 708202, 708206, 708209, 708228, 708250, 708352, 708397, 708418, 708429, 708435, 708436, 708450, 708536, 708577, 708822, 708995, 709047, 709078, 709080, 709082, 709085, 709091, 709092, 709104, 709110, 709134, 709161, 709168, 709170, 709242, 709273, 709284, 709285, 709333, 709337, 709341, 709344, 709345, 709351, 709352, 709375, 709376, 709377, 709378, 709380, 709384, 709387, 709393, 709394, 709396, 709402, 709415, 709419, 709421, 709424, 709425, 709445, 709460, 709462, 709479, 709481, 709488, 709489, 709491, 709492, 709494, 709495, 709500, 709502, 709506, 709521, 709525, 709531, 709533, 709536, 709560, 709562, 709563, 709567, 709572, 709601, 709606, 709608, 709622, 709623, 709627, 709629, 709631, 709634, 709642, 709643, 709644, 709647, 709656, 709664, 709668, 709672, 709673, 709683, 709687, 709713, 709748, 709750, 709765, 709777, 709782, 709797, 709804, 709809, 709810, 709811, 709813, 709815, 709824, 709849, 709854, 709855, 709861, 709870, 709876, 709879, 709883, 709901, 709904, 709909, 709911, 709913, 709916, 709922, 709927, 709946, 709949, 709959, 709964, 709987, 709990, 709995, 710006, 710008, 710013, 710014, 710020, 710021, 710023, 710028, 710042, 710053, 710063, 710071, 710073, 710075, 710076, 710080, 710081, 710083, 710085, 710087, 710101, 710114, 710125, 710134, 710135, 710141, 710142, 710143, 710144, 710146, 710150, 710152, 710154, 710156, 710159, 710164, 710167, 710173, 710177, 710181, 710183, 710186, 710187, 710192, 710194, 710196, 710201, 710205, 710207, 710213, 710214, 710216, 710218, 710222, 710228, 710242, 710244, 710245, 710247, 710248, 710249, 710250, 710254, 710259, 710265, 710274, 710275, 710281, 710283, 710285, 710286, 710290, 710295, 710299, 710301, 710307, 710309, 710314, 710316, 710329, 710339, 710361, 710363, 710366, 710382, 710400, 710401, 710402, 710425, 710430, 710438, 710447, 710456, 710468, 710470, 710475, 710476, 710506, 710508, 710612, 710615, 710643, 710652, 710654, ... | The agency lot list is longer than this excerpt. [Read the complete list at the official source](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0083-2026%22). Match all identifying details in the current notice. A brand name alone is not enough. ## Distribution Worldwide No US distribution state could be established from this record. Check the official notice. ## Dates in the source - **Report date**: Oct 22, 2025 - **Recall initiation date**: Aug 20, 2025 - **Center classification date**: Oct 10, 2025 FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0083-2026%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [Boston Scientific Corporation records](https://isitonrecall.com/brand/boston-scientific-corporation/)