Proponent SR Sl recalled by Boston Scientific

Yes. Boston Scientific recalled Proponent SR Sl ( on 20 Aug 2025. The recall is Class I and its status is Ongoing. Recall number Z-0085-2026.

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).

GTIN 00802526559020, Serial numbers: 722605, 722614, 722634, 722647. GTIN 00802526576362, Serial numbers: 464359, 464382, 464387, 464444, 464447, 464457, 464462, 464471, 464505, 464511, 464514, 464517, 464521, 464525, 464527, 464541, 464549, 464552, 464554, 464561, 464576, 708351, 708451, 708466, 708471, 708495, 708513, 708514, 708515, 708516, 708517, 708525, 708529, 708532, 708533, 708536, 708618, 708619, 708620, 708622, 708623, 708624, 708625, 708627, 708630, 708651, 708653, 708654, 708655, 708656, 708658, 708660, 708737, 708751, 708764, 708783, 708816, 708824, 708826, 708857, 708862, 708867, 708868, 708879, 708880, 708885, 708887, 708889, 708894, 708898, 708912, 708920, 708922, 708924, 708929, 708939, 708942, 708944, 708945, 708946, 708947, 708948, 708949, 708952, 708959, 708960, 708967, 708968, 708969, 708976, 708980, 708983, 708997, 709003, 709009, 709011, 709015, 709024, 709025, 709037, 709040, 709041, 710248, 710517, 710627, 710705, 710754, 710765, 710771, 710772, 710788, 710789, 710790, 710824, 710825, 710831, 710889, 710905, 710907, 710910, 710916, 710931, 710954, 710980, 711315, 711412, 711640, 711655, 714062, 714644, 714688, 714708, 715328, 717903, 717931, 717934, 717941, 717948, 717950, 717951, 717965, 717976, 717981, 717982, 717992, 718007, 718009, 718138, 718522, 718780, 718783, 718937, 720309, 720504, 720556, 720597, 720650, 721983, 721991, 722012, 722438, 722565, 722689, 722724, 722756, 722967, 723456, 724170, 724319, 724398, 724404, 724485, 724623, 725175, 725182, 725198, 725262, 725272, 725283, 725363, 725365, 725368, 725370, 725371, 725372, 725373, 725383, 725388, 725389, 725390, 725392, 725404, 725409, 725418, 725419, 725425, 725444, 727098, 728855, 728893, 728894, 728917, 728922, 729054, 729410, 729411, 729413, 729421, 729589, 729599, 729602, 731110, 731612, 734834. GTIN 00802526578007, Serial Numbers: 464370, 464388, 464446, 464452, 464458, 464460, 464467, 464468, 464470, 464475, 464477, 464481, 464482, 464483, 464486, 464490, 464491, 464492, 464498, 464500, 464501, 464506, 464508, 464512, 464516, 464519, 464523, 464526, 464528, 464532, 464563, 464568, 464570, 464590, 705011, 705236, 705383, 705409, 705419, 705462, 705468, 705555, 705576, 705584, 705622, 705628, 705702, 705706, 705711, 705713, 705728, 705751, 705753, 705795, 705812, 706007, 706098, 706215, 706321, 706350, 706372, 706698, 706846, 706879, 706918, 706923, 706931, 706947, 706967, 707053, 707069, 707089, 707138, 707173, 708261, 708473, 708494, 708504, 708528, 708534, 708546, 708549, 708585, 708589, 708595, 708629, 708652, 708657, 708721, 708722, 708723, 708749, 708750, 708752, 708770, 708774, 708775, 708776, 708780, 708797, 708798, 708802, 708815, 708819, 708820, 708831, 708832, 708841, 708843, 708844, 708848, 708851, 708853, 708858, 708859, 708874, 708877, 708883, 708886, 708892, 708896, 708905, 708907, 708910, 708913, 708914, 708915, 708916, 708917, 708918, 708923, 708925, 708928, 708930, 708932, 708933, 708935, 708936, 708937, 708938, 708940, 708941, 708943, 708950, 708956, 708958, 708965, 708966, 708971, 708974, 708975, 708977, 708978, 708981, 708982, 708984, 708986, 708987, 708992, 709000, 709002, 709004, 709006, 709007, 709008, 709012, 709013, 709014, 709016, 709023, 709027, 709029, 709033, 709034, 709039, 709042, 709043, 709044, 709045, 710352, 710458, 710499, 710501, 710532, 710562, 710568, 710569, 710577, 710667, 710675, 710676, 710727, 710729, 710735, 710739, 710766, 710769, 710796, 710801, 710802, 710808, 710811, 710820, 710895, 710897, 710903, 710921, 710957, 710982, 711020, 711082, 711102, 711225, 711231, 711235, 711286, 711314, 711328, 711345, 711353, 711354, 711356, 711455, 711473, 711530, 711534, 711546, 711552, 711562, 711569, 711577, 711594, 711596, 711598, 711599, 711604, 711611, 711614, 711616, 711617, 711619, 711641, 711763, 711765, 711768, 711776, 711777, 711780, 711791, 711795, 711804, 711814, 711823, 711839, 711852, 711863, 711865, 711866, 711868, 711870, 711872, 711875, 711887, 711890, 711893, 711894, 711899, 711910, 711914, 711915, 711917, 711924, 711925, 711926, 711928, 711931, 711938, 711942, 711946, 711947, 711954, 711963, 711970, 711971, 711980, 711982, 711987, 711997, 712009, 712017, 712026, 712053, 712056, 712058, 712084, 712086, 712088, 712093, 712098, 712107, 712125, 712129, 712131, 712137, 712145, 712174, 712177, 712178, 712210, 712219, 712232, 712239, 712249, 712255, 712256, 712257, 712264, 712279, 712284, 712286, 712290, 712302, 712312, 712321, 712350, 712352, 712385, 712390, 712396, 712397, 712410, 712414, 712428, 712436, 712442, 712449, 712459, 712470, 712475, 712477, 712489, 712521, 712534, 712537, 712571, 712598, 712631, 712716, 712742, 712750, 712751, 712820, 712829, 712843, 712848, 712860, 712862, 712864, 712868, 712875, 712882, 713006, 713041, 713048, 713052, 713053, 713054, 713055, 713056, 713058, 713060, 713062, 713063, 713073, 713074, 713083, 713125, 713126, 714102, 714105, 714164, 714206, 714221, 714223, 714226, 714246, 714260, 714261, 714307, 714338, 714345, 714358, 714360, 714361, 714374, 714443, 714518, 714546, 714550, 714599, 714622, 714631, 714638, 714646, 714647, 714651, 714653, 714657, 714660, 714683, 714690, 714692, 714694, 714695, 714699, 714707, 714709, 714710, 714719, 714744, 714748, 714754, 714761, 714785, 714791, 714827, 715038, 715040, 715041, 715042, 715058, 715106, 715124, 715205, 715237, 715241, 715243, 715258, 715260, 715273, 715278, 715279, 715284, 715285, 715287, 715289, 715293, 715297, 715300, 715304, 715317, 715325, 715327, 715332, 715333, 716079, 716137, 716179, 716191, 716196, 716203, 716204, 716306, 716353, 716354, 716356, 716370, 716385, 716411, 716420, 716449, 716861, 716864, 716915, 716926, 716927, 716930, 716931, 716933, 716935, 716937, 716938, 716940, 716944, 716947, 716948, 716949, 716950, 716951, 716964, 716965, 716966, 716974, 716978, 716986, 716987, 716989, 716991, 717163, 717181, 717194, 717197, 717199, 717200, 717201, 717202, 717203, 717204, 717205, 717339, 717356, 717357, 717358, 717359, 717360, 717361, 717369, 717374, 717377, 717383, 717385, 717392, 717393, 717395, 717401, 717402, 717423, 717514, 717624, 717755, 717784, 717786, 717795, 717796, 717797, 717798, 717799, 717800, 717805, 717918, 717925, 717930, 717936, 717949, 717953, 717954, 717955, 717968, 717972, 717983, 718008, 718014, 718054, 718060, 718061, 718067, 718072, 718074, 718079, 718080, 718085, 718086, 718091, 718098, 718109, 718113, 718117, 718120, 718128, 718134, 718136, 718169, 718204, 718205, 718217, 718224, 718395, 718420, 718446, 718447, 718448, 718449, 718450, 718467, 718697, 718711, 718719, 718728, 718769, 718774, 718775, 718782, 718784, 718795, 718921, 718923, 718932, 718991, 719000, 719003, 719007, 719009, 719034, 719040, 719041, 719080, 719097, 719099, 719156, 719160, 719182, 719186, 719196, 719198, 719211, 719230, 719236, 719237, 719239, 719248, 719252, 719253, 719255, 719261, 719265, 719270, 719271, 719301, 719357, 719367, 719372, 719373, 719376, 719379, 719421, 719453, 719456, 719460, 719730, 719752, 719753, 719754, 719755, 719756, 719759, 719761, 719894, 719925, 719929, 719943, 719969, 719972, 720012, 720019, 720109, 720110, 720119, 720122, 720124, 720132, 720134, 720135, 720141, 720142, 720144, 720145, 720147, 720150, 720154, 720172, 720173, 720183, 720184, 720191, 720198, 720228, 720234, 720240, 720242, 720250, 720502, 720503, 720538, 720541, 720593, 720600, 720604, 720611, 720618, 720633, 720641, 720660, 720663, 720697, 720729, 720767, 720782, 720792, 720793, 720801, 720832, 720858, 720859, 720874, 720920, 720931, 720943, 720961, 720981, 721004, 721204, 721205, 721213, 721219, 721228, 721230, 721276, 721812, 721872, 721884, 721977, 722030, 722046, 722047, 722178, 722180, 722181, 722333, 722448, 722479, 722539, 722558, 722569, 722570, 722578, 722580, 722612, 722639, 722655, 722668, 722671, 722703, 722705, 722808, 722822, 722843, 722844, 722905, 722906, 722910, 722917, 722921, 722930, 722933, 722944, 722945, 722947, 722948, 722949, 722957, 722958, 722962, 722963, 722964, 722965, 722968, 722969, 722970, 723010, 723298, 723305, 723317, 723580, 723713, 723745, 723749, 723751, 723755, 723766, 723772, 723775, 723777, 723779, 723782, 723784, 723794, 723802, 723830, 724358, 724397, 724400, 724436, 724443, 724448, 724456, 724471, 724496, 724500, 724739, 725060, 725063, 725073, 725074, 725077, 725078, 725083, 725086, 725088, 725100, 725102, 725108, 725112, 725115, 725121, 725132, 725156, 725165, 725179, 725193, 725200, 725202, 725247, 725266, 725270, 725273, 725274, 725275, 725276, 725277, 725279, 725281, 725285, 725288, 725289, 725290, 725291, 725296, 725298, 725300, 725302, 725304, 725305, 725306, 725307, 725308, 725309, 725312, 725322, 725339, 725367, 725386, 725407, 725449, 725459, 725460, 725484, 725659, 725697, 725699, 725703, 725704, 725706, 725710, 725742, 725747, 725750, 725753, 725755, 725756, 725757, 725758, 725759, 725760, 725761, 725765, 725766, 725769, 725772, 725773, 725774, 725776, 725786, 725792, 725888, 725889, 725906, 725909, 725911, 725915, 725917, 725922, 725923, 725957, 726031, 726034, 726061, 726089, 726117, 726118, 726119, 726121, 726125, 726144, 726156, 726160, 726166, 726168, 726169, 726171, 726173, 726175, 726177, 726178, 726179, 726184, 726185, 726187, 726193, 726197, 726199, 726200, 726205, 726209, 726220, 726227, 726228, 726358, 726576, 726591, 726596, 726600, 726619, 726625, 726682, 726772, 726943, 726945, 727060, 727062, 727063, 727064, 727065, 727087, 727092, 727096, 727139, 727140, 727160, 727442, 727559, 727575, 727590, 727595, 727678, 727679, 727729, 727739, 727877, 727879, 727885, 727892, 727906, 727935, 727941, 728077, 728110, 728120, 728121, 728123, 728124, 728125, 728136, 728139, 728357, 728371, 728438, 728445, 728447, 728449, 728454, 728465, 728467, 728468, 728469, 728473, 728474, 728493, 728500, 728505, 728516, 728529, 728530, 728534, 728537, 728557, 728558, 728634, 728666, 728677, 728846, 728849, 728850, 728851, 728854, 728919, 728926, 728944, 729047, 729050, 729057, 729059, 729060, 729062, 729065, 729134, 729136, 729138, 729141, 729155, 729157, 729166, 729170, 729187, 729206, 729211, 729414, 729417, 729436, 729438, 729451, 729456, 729513, 729524, 729568, 729573, 729575, 729576, 729632, 729634, 729635, 729637, 729640, 729655, 729656, 729659, 729661, 729685, 730227, 730349, 731139, 731159, 731183, 731184, 731189, 731208, 731210, 731217, 731224, 731228, 731239, 731241, 731249, 731296, 731331, 731332, 731337, 731342, 731343, 731351, 731364, 731368, 731370, 731408, 731415, 731423, 731439, 731452, 731453, 731455, 731462, 731466, 731468, 731471, 731634, 731669, 731773, 731781, 731800, 731815, 731824, 731830, 731878, 731886, 731888, 731932, 731967, 731970, 731972, 731974, 731980, 731986, 731992, 731999, 732280, 732321, 732430, 732436, 732682, 732694, 732749, 732898, 732903, 732913, 733412, 733461, 733496, 733499, 733501, 733533, 733535, 733536, 733537, 733539, 733540, 733926, 733954, 733961, 734000, 734423, 734499, 734508, 734514, 734535, 734563, 734575, 734676, 734682, 734729, 734842, 734886, 734979, 734986, 734989, 734997, 735022, 735024, 735032, 735037, 735038, 735047, 735051, 735055, 735061, 735062, 735063, 735066, 735070, 735075, 735078, 735084, 735094, 735604.

Worldwide

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.