--- title: "PROPONENT DR SL (Model L201) — FDA record Z-0086-2026 | 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-0086-2026-proponent-dr-sl-model-l201/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # PROPONENT DR SL (Model L201) — FDA record Z-0086-2026 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**: PROPONENT DR SL (Model L201) - **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**: 2,426 units - **Agency-reported status**: Ongoing - **Source record identifier**: Z-0086-2026 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0086-2026%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 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, 725787, 726012, 726021, 726027, 726030, 726077, 726083, 726100, 726115, 726129, 726151, 726160, 726176, 726178, 726197, 726202, 726255, 726268, 726278, 726385, 726393, 726425, 726489, 726529, 726546, 726552, 726563, 726569, 726576, 726580, 726596, 726600, 726637, 726650, 726708, 726710, 726717, 726718, 726723, 726733, 726736, 726747, 726791, 726806, 726822, 727141, 727202, 733301, 734188, 735930, 736415, 736900, 737251, 737289, 737295, 737979, 737999, 738250, 738466, 738516, 738537, 738571, 738601, 738617, 738692, 738706, 739854, 739903, 739919, 739927, 739980, 740026, 740088, 740090, 740099, 743253, 743301, 743383, 743454, 743456, 744006, 744019, 744022, 744026, 744029, 744030, 744033, 744050, 744053, 744056, 744057, 744060, 744072, 744078, 744090, 746102, 746341, 746374, 753828, 753928, 753999, 754447, 754459, 758922, 759048, 759138, 759174, 759392, 759429, 759434, 759437, 759524, 759529, 760210, 761632, 762336, 762356, 762499, 762509, 762548, 762549, 764563, 765812, 765865, 766827, 766840, 767280, 767281, 767282, 767284, 767291, 767326, 767349, 767744, 767797, 767963, 768117, 768153, 768243, 768261, 768276, 768282, 768283, 768286, 768295, 768296, 768314, 768608, 768656, 768739, 768752, 768786, 768814, 768836, 768849, 768905, 768999, 771813, 771819, 779667, 779978, 779986, 779993, 779994, 780001, 780074, 780123, 780142, 780144, 780165, 780199, 780270, 780292, 780306, 780308, 780330, 780332, 780335, 780336, 780813, 780864, 780871, 780872, 797686, 797691, 797710, 797713, 797718. GTIN 00802526576874, Serial numbers: 715757, 715779, 715795, 715799, 715805, 715842, 715905, 715993, 716005, 716044, 716045, 716063, 716066, 716148, 716182, 716190, 716208, 716250, 716292, 716306, 716315, 716423, 716514, 716543, 716610, 716629, 716680, 716715, 716721, 716759, 716779, 716803, 717000, 717018, 717053, 717070, 717098, 717099, 717108, 717153, 717156, 717166, 717197, 717302, 717306, 717313, 717369, 717378, 717413, 717593, 717600, 717700, 717816, 717878, 717896, 717906, 717931, 717963, 717994, 717996, 718005, 718137, 718418, 718494, 718504, 718528, 718552, 718601, 718605, 718608, 718617, 718627, 718630, 718631, 718640, 718659, 718667, 718668, 718675, 718697, 718711, 718713, 718716, 718733, 718762, 718778, 718784, 718794, 718801, 718805, 718806, 718820, 718833, 718881, 718882, 718890, 718892, 718893, 718894, 718896, 718900, 718908, 718914, 718972, 718989, 719045, 724678, 724683, 724783, 724818, 725894, 725949, 736403, 737513, 737926, 737997, 738014, 738721, 738746, 738764, 738794, 738825, 738834, 738836, 739420, 739936, 740178, 740375, 741218, 741219, 741287, 741696, 741730, 741970, 742033, 742045, 742079, 742107, 742206, 742209, 742215, 742267, 742274, 742295, 742324, 742331, 742337, 742435, 742443, 742444, 742475, 742491, 742532, 742566, 742606, 742607, 742613, 742614, 742620, 742621, 742640, 742667, 742815, 742849, 742858, 742866, 742878, 742885, 742931, 742960, 742985, 743012, 743064, 743086, 743093, 743102, 743137, 743141, 743205, 743343, 743353, 743362, 743985, 743989, 744018, 744028, 744048, 744051, 744071, 744087, 745089, 745110, 745704, 745739, 745754, 745805, 745827, 745833, 745858, 745878, 745881, 745888, 745904, 745907, 745909, 745910, 745911, 745915, 745916, 745922, 745935, 745936, 745942, 745945, 745946, 745948, 745950, 745954, 745959, 745960, 745964, 745965, 745966, 745971, 745972, 745975, 745977, 745987, 746011, 746018, 746021, 746030, 746034, 746035, 746047, 746050, 746051, 746058, 746059, 746062, 746065, 746066, 746067, 746068, 746069, 746073, 746076, 746079, 746082, 746086, 746089, 746093, 746096, 746103, 746115, 746117, 746122, 746124, 746125, 746144, 746152, 746189, 746248, 746257, 746368, 746376, 746389, 750690, 751125, 751479, 752229, 752296, 752312, 752409, 752607, 752660, 752676, 752894, 752929, 753368, 753857, 754853, 754863, 754866, 754876, 754878, 754882, 754884, 754939, 754946, 754961, 760408, 760539, 760542, 760544, 760548, 760549, 760553, 760832, 760860, 760870, 760881, 760939, 761502, 761519, 761570, 763356, 763704, 763987, 764009, 764040, 764047, 764054, 764055, 764074, 764079, 764080, 764087, 764088, 764089, 764098, 764099, 764101, 764109, 764126, 764127, 764135, 764147, 764149, 764166, 764171, 764201, 764280, 764321, 764404, 764470, 766207, 766216, 781345, 781358, 781386, 781394, 781397, 781411, 781415, 781417, 781432, 781440, 781931, 781942, 782015, 782019, 782026, 782037, 782075, 782076, 782088, 782091, 782095, 782099, 782112, 782113, 782115, 782120, 782122, 782133, 782144, 782145, 782151, 782153, 782179, 782180, 782184, 782233, 782245, 782253, 782264, 782275, 782315, 782326, 782327, 782329, 782330, 782352, 782357, 782365, 782367, 782378, 782382, 782392, 782395, 782399, 782410, 782434, 782470, 782473, 782475, 782477, 782479, 782483, 782485, 782491, 782501, 782504, 782506, 782661, 782664, 782668, 782669, 782670, 782671. 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[Read the complete list at the official source](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0086-2026%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-0086-2026%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [Boston Scientific Corporation records](https://isitonrecall.com/brand/boston-scientific-corporation/)