FDAFDA · Food and drugs·Recall number Z-0089-2026
Model Number L211 PROPONENT DR SL 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 00802526559105, Serial Numbers: 296409, 658411. GTIN 00802526576409, Serial Numbers: 431535. GTIN 00802526578038, Serial Numbers: 251896, 375153, 396268. GTIN 00802526559105, Serial Numbers: 100009, 100020, 100022, 100024, 100028, 100030, 100031, 100037, 100038, 100039, 100043, 100046, 100047, 100048, 100049, 100052, 100053, 100058, 100061, 100063, 100066, 100068, 100075, 100077, 100078, 100080, 100083, 100087, 100090, 100091, 100095, 100097, 100098, 100106, 100113, 100122, 100125, 100127, 100130, 100131, 100132, 100133, 100143, 100145, 100156, 100158, 100163, 100166, 100167, 100168, 100170, 100172, 100174, 100175, 100179, 100187, 100188, 100191, 100194, 100198, 100206, 100207, 100209, 100210, 100213, 100217, 100218, 100219, 100220, 100221, 100222, 100223, 100224, 100225, 100226, 100230, 100231, 100237, 100244, 100246, 100247, 100248, 100249, 100268, 100269, 100270, 100271, 100275, 100280, 100281, 100290, 100291, 100309, 100316, 100334, 100390, 100395, 100398, 100427, 100430, 100438, 100446, 100460, 100462, 100478, 100482, 100487, 100488, 100493, 100497, 100505, 100509, 100510, 100513, 100514, 100516, 100522, 100527, 100529, 100532, 100537, 100542, 100551, 100555, 100559, 100565, 100567, 100571, 100576, 100578, 100580, 100584, 100585, 100592, 100594, 100598, 100600, 100601, 100606, 100612, 100613, 100617, 100618, 100619, 100621, 100622, 100623, 100631, 100634, 100638, 100643, 100647, 100648, 100649, 100651, 100652, 100653, 100659, 100660, 100668, 100669, 100670, 100672, 100674, 100677, 100680, 100684, 100685, 100700, 100702, 100705, 100708, 100710, 100711, 100717, 100720, 100722, 100723, 100727, 100730, 100731, 100733, 100742, 100746, 100747, 100753, 100755, 100767, 100769, 100772, 100776, 100778, 100782, 100783, 100784, 100789, 100794, 100796, 100799, 100811, 100814, 100815, 100816, 100818, 100820, 100825, 100828, 100829, 100836, 100839, 100840, 100843, 100853, 100854, 100861, 100864, 100866, 100870, 100873, 100874, 100876, 100877, 100879, 100881, 100883, 100884, 100885, 100887, 100896, 100899, 100902, 100903, 100906, 100909, 100913, 100915, 100917, 100918, 100920, 100922, 100923, 100930, 100931, 100934, 100937, 100941, 100950, 100953, 100957, 100961, 100964, 100971, 100973, 100976, 100997, 101002, 101003, 101005, 101015, 101018, 101022, 101024, 101025, 101026, 101033, 101034, 101036, 101038, 101040, 101041, 101049, 101054, 101062, 101063, 101065, 101069, 101074, 101078, 101079, 101083, 101085, 101087, 101089, 101090, 101092, 101097, 101098, 101099, 101100, 101101, 101102, 101104, 101107, 101109, 101110, 101113, 101115, 101118, 101119, 101120, 101121, 101127, 101130, 101133, 101136, 101139, 101141, 101142, 101143, 101145, 101147, 101148, 101152, 101153, 101154, 101155, 101159, 101171, 101174, 101179, 101182, 101187, 101188, 101189, 101190, 101191, 101195, 101196, 101199, 101200, 101202, 101205, 101207, 101209, 101211, 101218, 101224, 101226, 101236, 101237, 101238, 101241, 101243, 101246, 101251, 101253, 101263, 101266, 101268, 101269, 101270, 101294, 101295, 101303, 101306, 101308, 101313, 101315, 101319, 101323, 101329, 101334, 101341, 101342, 101344, 101346, 101348, 101349, 101351, 101354, 101358, 101362, 101366, 101368, 101369, 101370, 101371, 101375, 101378, 101379, 101380, 101390, 101391, 101394, 101397, 101408, 101410, 101412, 101418, 101422, 101425, 101427, 101429, 101433, 101435, 101440, 101441, 101442, 101443, 101447, 101448, 101454, 101458, 101466, 101469, 101471, 101472, 101481, 101482, 101483, 101490, 101494, 101497, 101499, 101500, 101502, 101506, 101508, 101511, 101516, 101517, 101518, 101521, 101523, 101524, 101527, 101528, 101530, 101531, 101532, 101535, 101537, 101542, 101548, 101556, 101559, 101562, 101568, 101570, 101575, 101578, 101584, 101588, 101590, 101591, 101592, 101598, 101599, 101600, 101601, 101602, 101609, 101616, 101620, 101628, 101636, 101642, 101654, 101658, 101663, 101664, 101670, 101673, 101676, 101678, 101680, 101681, 101685, 101687, 101692, 101693, 101695, 101706, 101715, 10
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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