---
title: "ACCOLADE SR SL (Model L300) — FDA record Z-0079-2026 | 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-0079-2026-accolade-sr-sl-model-l300/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# ACCOLADE SR SL (Model L300) — FDA record Z-0079-2026

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 SR SL (Model L300)
- **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**: 16,077 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0079-2026

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0079-2026%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 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, 464708, 464712, 464715, 464720, 464721, 464726, 464730, 464734, 464736, 464738, 464740, 464741, 464743, 464744, 464745, 464746, 464749, 464750, 464751, 464754, 464758, 464761, 464766, 464767, 464771, 464772, 464774, 464775, 464776, 464778, 464779, 464781, 464784, 464787, 464788, 464795, 464796, 464797, 464800, 464805, 464806, 464807, 464810, 464811, 464821, 464824, 464825, 464828, 464830, 464831, 464833, 464837, 464838, 464843, 464848, 464852, 464857, 464858, 464859, 464860, 464870, 464883, 464891, 464893, 464899, 464900, 464901, 464902, 464926, 465020, 465058, 465118, 465121, 465147, 465171, 465179, 465187, 465191, 465196, 465203, 465204, 465205, 465215, 465217, 465219, 465228, 465230, 465231, 465244, 465254, 465255, 465256, 465267, 465269, 465272, 465275, 465278, 465280, 465291, 465295, 465298, 465310, 465313, 465315, 465323, 465324, 465325, 465327, 465331, 465333, 465337, 465338, 465339, 465342, 465346, 465349, 465350, 465355, 465356, 465360, 465363, 465365, 465368, 465369, 465374, 465375, 465379, 465388, 465390, 465393, 465395, 465405, 465413, 465500, 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704817, 704821, 704837, 704838, 704844, 704850, 704853, 704871, 704875, 704877, 704878, 704880, 704881, 704882, 704883, 704884, 704885, 704893, 704896, 704898, 704899, 704901, 704902, 704906, 704910, 704911, 704913, 704914, 704916, 704920, 704926, 704934, 704936, 704938, 704945, 704948, 704953, 704958, 704968, 704979, 704981, 704986, 704988, 704989, 704990, 704993, 704996, 705022, 705024, 705032, 705035, 705037, 705043, 705044, 705050, 705054, 705071, 705075, 705086, 705092, 705093, 705097, 705107, 705120, 705152, 705173, 705186, 705187, 705199, 705206, 705207, 705220, 705224, 705240, 705241, 705242, 705249, 705251, 705265, 705269, 705283, 705288, 705290, 705293, 705299, 705304, 705307, 705322, 705323, 705325, 705339, 705349, 705351, 705353, 705373, 705385, 705386, 705389, 705390, 705408, 705410, 705424, 705425, 705434, 705435, 705438, 705441, 705446, 705452, 705457, 705464, 705479, 705485, 705488, 705497, 705499, 705500, 705508, 705512, 705522, 705528, 705529, 705536, 705537, 705539, 705553, 705559, 705561, 705564, 705578, 705582, 705592, 705598, 705600, 705606, 705607, 705619, 705633, 705636, 705637, 705640, 705643, 705645, 705700, 705708, 705709, 705710, 705712, 705720, 705727, 705729, 705731, 705742, 705744, 705755, 705756, 705758, 705764, 705793, 705794, 705805, 705806, 705816, 705824, 705827, 705832, 705844, 705845, 705883, 705901, 705906, 705909, 705912, 705921, 705935, 705943, 705974, 705975, 705984, 706037, 706038, 706039, 706053, 706059, 706125, 706129, 706132, 706155, 706161, 706163, 706167, 706182, 706186, 706191, 706193, 706213, 706219, 706225, 706238, 706266, 706274, 706301, 706345, 706374, 706381, 706391, 706393, 706398, 706407, 706438, 706451, 706463, 706467, 706472, 706475, 706496, 706539, 706569, 706605, 706668, 706674, 706680, 706707, 706709, 706748, 706772, 706780, 706791, 706792, 706824, 706829, 706837, 706842, 706845, 706852, 706863, 706868, 706869, 706872, 706960, 707001, 707038, 707043, 707068, 707071, 707077, 707079, 707088, 707105, 707146, 707156, 707160, 707161, 707190, 707209, 707210, 707217, 707225, 707245, 707247, 707251, 707256, 707258, 707268, 707274, 707276, 707287, 707288, 707304, 707323, 707329, 707344, 707345, 707355, 707357, 707366, 707372, 707373, 707379, 707384, 707402, 707411, 707438, 707445, 707454, 707455, 707461, 707477, 707487, 707498, 707504, 707509, 707525, 707528, 707537, 707543, 707545, 707557, 707560, 707577, 707582, 707604, 707606, 707620, 707631, 707639, 707645, 707656, 707662, 707682, 707698, 707699, 707704, 707708, 707720, 707723, 707748, 707752, 707766, 707786, 707795, 707802, 707804, 707826, 707827, 707838, 707848, 707860, 707868, 707894, 707895, 707905, 707915, 707917, 707923, 707932, 707956, 707958, 707977, 707988, 707989, 707996, 708042, 708060, 708067, 708073, 708086, 708099, 708117, 708126, 708148, 708151, 708174, 708183, 708199, 708201, 708206, 708211, 708223, 708230, 708245, 708253, 708258, 708264, 708275, 708291, 708306, 708307, 708327, 708344, 708348, 708353, 708354, 708363, 708365, 708367, 708375, 708381, 708413, 708424, 708425, 708434, 708480, 708496, 708500, 708521, 708524, 708526, 708535, 708543, 708547, 708553, 708561, 708587, 708597, 708614, 708616, 708621, 708727, 708728, 708729, 708731, 708736, 708739, 708748, 708753, 708760, 708763, 708767, 708772, 708779, 708791, 708810, 708813, 708829, 708830, 708833, 708835, 708838, 708846, 708869, 708873, 708900, 708902, 708904, 708957, 708996, 709010, 709035, 709070, 709074, 709081, 709087, 709099, 709113, 709123, 709131, 709145, 709160, 709166, 709180, 709181, 709182, 709186, 709201, 709203, 709204, 709205, 709207, 709208, 709210, 709213, 709216, 709224, 709225, 709233, 709234, 709243, 709256, 709265, 709266, 709272, 709276, 709281, 709283, 709288, 709289, 709293, 709294, 709296, 709298, 709300, 709308, 709313, 709315, 709316, 709318, 709320, 709321, 709324, 709327, 709329, 709330, 709332, 709333, 709334, 709337, 709338, 709343, 709345, 709346, 709353, 709366, 709370, 709377, 709380, 709382, 709384, 709392, 709396, 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711418, 711427, 711429, 711431, ... |

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-0079-2026%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-0079-2026%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Boston Scientific Corporation records](https://isitonrecall.com/brand/boston-scientific-corporation/)
