FDAFDA · Food and drugs·Recall number Z-0091-2026
Model Number L231, PROPONENT DR EL MRI Pacemaker
Published October 22, 2025 · Recall initiated: August 20, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Boston Scientific Corporation
- Distributor
- Worldwide
- Lot
- GTIN 00802526559143, Serial Numbers: 756161, 799038, 841168. GTIN 00802526576423, Serial Numbers: 532638, 880141, 973836. GTIN 00802526578052, Serial Numbers: 594082, 727921, 812172, 832267, 899037, 944246, 978524. GTIN 00802526559143, Serial Numbers: 100008, 100026, 100030, 100038, 100045, 100046, 100052, 100053, 100059, 100061, 100066, 100077, 100078, 100079, 100081, 100083, 100087, 100088, 100099, 100104, 100105, 100108, 100114, 100126, 100130, 100134, 100136, 100142, 100148, 100151, 100153, 100154, 100156, 100161, 100162, 100163, 100164, 100165, 100168, 100172, 100175, 100178, 100180, 100181, 100187, 100188, 100190, 100191, 100193, 100196, 100199, 100201, 100203, 100205, 100206, 100207, 100208, 100210, 100212, 100213, 100216, 100218, 100220, 100235, 100236, 100243, 100244, 100245, 100246, 100247, 100251, 100252, 100253, 100254, 100256, 100261, 100265, 100275, 100279, 100280, 100282, 100283, 100288, 100289, 100292, 100293, 100294, 100296, 100299, 100300, 100302, 100305, 100306, 100307, 100308, 100309, 100310, 100314, 100316, 100317, 100318, 100322, 100326, 100327, 100328, 100329, 100333, 100335, 100339, 100340, 100341, 100342, 100345, 100348, 100350, 100352, 100358, 100361, 100364, 100365, 100366, 100367, 100368, 100370, 100371, 100372, 100373, 100375, 100376, 100377, 100379, 100381, 100389, 100395, 100409, 100411, 100412, 100414, 100415, 100416, 100417, 100418, 100438, 100439, 100441, 100442, 100443, 100444, 100445, 100447, 100448, 100449, 100450, 100451, 100452, 100454, 100455, 100456, 100458, 100459, 100460, 100461, 100462, 100463, 100464, 100465, 100466, 100467, 100468, 100469, 100471, 100472, 100473, 100474, 100475, 100476, 100477, 100479, 100480, 100481, 100482, 100483, 100484, 100488, 100491, 100494, 100497, 100507, 100516, 100517, 100518, 100519, 100523, 100529, 100531, 100532, 100541, 100543, 100554, 100555, 100558, 100560, 100566, 100586, 100588, 100589, 100595, 100596, 100598, 100609, 100610, 100613, 100614, 100623, 100624, 100625, 100627, 100628, 100629, 100631, 100633, 100634, 100637, 100638, 100640, 100641, 100647, 100648, 100649, 100650, 100651, 100652, 100654, 100656, 100659, 100662, 100665, 100666, 100667, 100668, 100673, 100674, 100675, 100676, 100677, 100678, 100679, 100680, 100681, 100682, 100683, 100684, 100688, 100691, 100693, 100695, 100698, 100699, 100700, 100703, 100708, 100709, 100710, 100713, 100718, 100720, 100722, 100723, 100725, 100726, 100727, 100728, 100729, 100730, 100731, 100732, 100733, 100734, 100735, 100736, 100738, 100746, 100750, 100755, 100756, 100758, 100759, 100764, 100767, 100768, 100769, 100775, 100780, 100781, 100782, 100784, 100800, 100801, 100802, 100804, 100809, 100816, 100831, 100841, 100885, 100889, 100892, 100899, 100902, 100904, 100910, 100912, 100919, 100927, 100933, 100953, 100972, 100991, 101003, 101012, 101028, 101030, 101289, 101327, 101341, 101356, 101357, 101366, 101383, 101389, 101391, 101394, 101407, 101412, 101417, 101419, 101433, 101439, 101441, 101445, 101449, 101451, 101452, 101455, 101461, 101463, 101473, 101475, 101477, 101480, 101490, 101495, 101498, 101500, 101505, 101511, 101514, 101516, 101524, 101525, 101532, 101539, 101552, 101554, 101558, 101559, 101562, 101563, 101574, 101576, 101577, 101580, 101587, 101589, 101595, 101599, 101604, 101606, 101609, 101610, 101611, 101613, 101618, 101626, 101629, 101631, 101641, 101680, 101682, 101685, 101687, 101688, 101690, 101713, 101720, 101728, 101736, 101739, 101750, 101753, 101755, 101760, 101764, 101765, 101768, 101769, 101773, 101774, 101776, 101782, 101787, 101788, 101794, 101795, 101796, 101808, 101811, 101813, 101815, 101822, 101823, 101825, 101829, 101832, 101834, 101835, 101836, 101841, 101843, 101852, 101857, 101858, 101859, 101864, 101868, 101869, 101871, 101873, 101880, 101882, 101884, 101886, 101888, 101890, 101891, 101892, 101893, 101896, 101899, 101900, 101901, 101908, 101911, 101918, 101922, 101923, 101924, 101928, 101932, 101933, 101934, 101935, 101936, 101937, 101938, 101940, 101941, 10
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.