Class I FDA device recall · Z-0086-2026

Class I — the FDA judged there is a reasonable probability that use of the product would cause serious harm or death.

This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone.

PROPONENT DR SL (Model L201)

Why it was recalled

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).

Is your unit affected?

The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.

A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.

Show the FDA's listed lot / code information

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.   GTIN 00802526578014, Serial Numbers:  100140, 100181, 100221, 100282, 100287, 100290, 100401, 100407, 100410, 100707, 100750, 100763, 100766, 100770, 100772, 100781, 100782, 100783, 100785, 100786, 100788, 100793, 100803, 100804, 100808, 100818, 100827, 100838, 100839, 713123, 714640, 714796, 715611, 715802, 715831, 715847, 715854, 715886, 715907, 715912, 715934, 715949, 715953, 715981, 715986, 715991, 716002, 716007, 716011, 716016, 716028, 716054, 716081, 716093, 716097, 716106, 716107, 716108, 716147, 716162, 716163, 716171, 716183, 716194, 716205, 716228, 716237, 716239, 716247, 716255, 716256, 716260, 716267, 716282, 716288, 716289, 716290, 716291, 716309, 716317, 716333, 716342, 716346, 716360, 716375, 716380, 716396, 716407, 716410, 716419, 716421, 716424, 716426, 716433, 716435, 716443, 716455, 716473, 716545, 716572, 716605, 716641, 716727, 716750, 716760, 716769, 716836, 716839, 716841, 716845, 716868, 716990, 716994, 716997, 717009, 717034, 717040, 717077, 717083, 717118, 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Recall status

Ongoing — the recall is still being carried out.

Where it was distributed

Worldwide

Recall record

Recalling firm: Boston Scientific Corporation
Product type: Devices
Recall number: Z-0086-2026
Voluntary / mandated: Voluntary: Firm initiated
Initial notification: Letter
Origin: Saint Paul, MN
Recall initiated: 2025-08-20

What to do

Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.

Also available: structured data (JSON-LD) · recall record (JSON)

What this is — and is not

A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.

To report a problem you experienced, use FDA MedWatch. Verify this record at FDA recalls · Recall Z-0086-2026 · Source: openFDA enforcement.