Model Number L221 PROPONENT DR EL Pacemaker

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    GTIN 00802526578045, Serial Numbers: 723080, 723248, 725570, 729255. GTIN 00802526559129. Serial Numbers: 732639. 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  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Boston Scientific Corporation
Reason for Recall:
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 - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Model Number L221 PROPONENT DR EL Pacemaker

Product Codes/Lot Numbers:

GTIN 00802526578045, Serial Numbers: 723080, 723248, 725570, 729255. GTIN 00802526559129. Serial Numbers: 732639. GTIN 00802526576416, Serial numbers: 100156, 100157, 100167, 100180, 100185, 100247, 100254, 100263, 100268, 100272, 100278, 100279, 100282, 100293, 100296, 100302, 100304, 100305, 100306, 100308, 100314, 100315, 100332, 100335, 100336, 100453, 702524, 702763, 703141, 703183, 703341, 703490, 704875, 705065, 705069, 706965, 707072, 707119, 707355, 707474, 707499, 707999, 708019, 708170, 708229, 709024, 712293, 712330, 712402, 712408, 712424, 712437, 712517, 713937, 714362, 714643, 714710, 714836, 714847, 715761, 715890, 716146, 716435, 716731, 717103, 717117, 717537, 718007, 718062, 718114, 718137, 718139, 718301, 718312, 719571, 719630, 719635, 719637, 719653, 719835, 720752, 720838, 721277, 721298, 721511, 721604, 722560, 723084, 723234, 723279, 723335, 723486, 723491, 723494, 723498, 723509, 723529, 723557, 723559, 723562, 723573, 723625, 724616, 724666, 724696, 724709, 724782, 724819, 724838, 724846, 724853, 724857, 724890, 724914, 725181, 725182, 725183, 725184, 725185, 725186, 725187, 725188, 725189, 725190, 725586, 725603, 725604, 725605, 725607, 725608, 725609, 725610, 725727, 725792, 725801, 726384, 726419, 726545, 726800, 726801, 726878, 727128, 727172, 727178, 727236, 727242, 727255, 727257, 727262, 727263, 727268, 727271, 727292, 727315, 727323, 727335, 727346, 727376, 727378, 727379, 727382, 728093, 728135, 728139, 728153, 728301, 728324, 728381, 728658, 728682, 728690, 728694, 728713, 728881, 728905, 728908, 728911, 728967, 728981, 728982, 729013, 729066, 729068, 729069, 729071, 729075, 729081, 729083, 729237, 729258, 729321, 729323, 729340, 729390, 729736, 730067, 730087, 730237, 730238, 730239, 731097, 731100, 731104, 731106, 731110, 731118, 731150, 731166, 731168, 731198, 731279, 731294, 731306, 733065, 733285, 733332, 733838, 734232, 734237, 734238, 734261, 735042. GTIN 00802526578045, Serial Numbers: 100200, 100307, 100313, 100316, 100327, 100329, 702672, 702711, 702810, 702921, 703010, 703011, 703012, 703080, 703124, 703130, 703143, 703149, 703156, 703177, 703180, 703184, 703185, 703189, 703195, 703204, 703228, 703230, 703234, 703235, 703243, 703244, 703252, 703256, 703257, 703265, 703267, 703268, 703270, 703272, 703273, 703279, 703283, 703284, 703288, 703296, 703297, 703298, 703299, 703300, 703303, 703307, 703311, 703312, 703313, 703315, 703322, 703323, 703329, 703439, 703485, 703487, 703488, 704720, 704832, 704879, 704883, 704911, 704935, 704939, 704943, 704957, 704963, 704993, 705071, 705073, 705074, 705207, 705209, 705240, 705639, 706096, 706447, 706517, 706548, 706554, 706562, 706568, 706577, 706579, 706616, 706647, 706682, 706684, 706734, 706765, 706766, 706824, 706846, 706858, 706891, 706912, 706913, 706920, 706923, 706926, 706936, 706946, 706956, 706991, 707016, 707043, 707101, 707111, 707115, 707116, 707117, 707138, 707144, 707149, 707160, 707171, 707172, 707188, 707205, 707216, 707220, 707232, 707264, 707284, 707301, 707342, 707358, 707359, 707453, 707491, 707523, 707528, 707540, 707547, 707551, 707552, 707600, 707750, 707782, 707879, 707895, 707917, 707930, 707953, 707990, 708100, 708117, 708126, 708159, 708225, 708332, 708413, 708414, 708427, 708434, 708444, 708479, 708480, 708488, 708490, 708497, 708500, 708505, 708506, 708507, 708511, 708513, 708514, 708516, 708520, 708525, 708528, 708531, 708548, 708551, 708559, 708562, 708563, 708567, 708573, 708575, 708578, 708581, 708583, 708584, 708585, 708590, 708597, 708600, 708601, 708606, 708607, 708610, 708612, 708614, 708617, 708624, 708625, 708634, 708639, 708640, 708643, 708644, 708645, 708647, 708648, 708654, 708657, 708659, 708665, 708692, 708700, 708703, 708714, 708751, 708753, 708756, 708757, 708760, 708761, 708762, 708763, 708837, 708846, 708849, 708851, 708860, 708889, 708890, 708918, 708920, 708925, 708927, 708945, 708955, 708981, 708990, 709028, 709029, 709032, 709036, 709040, 709041, 709046, 709049, 709051, 709054, 709057, 709060, 709065, 709067, 709070, 709074, 709075, 709083, 709101, 709103, 709108, 709112, 709114, 709120, 709127, 709128, 709130, 709137, 709142, 709150, 709154, 709155, 709156, 709157, 709159, 709173, 709178, 709189, 709193, 709194, 709208, 709221, 710700, 710729, 710743, 710745, 710755, 710810, 710826, 710842, 710863, 710868, 710885, 710890, 710904, 710906, 710907, 710908, 710916, 710942, 710989, 710996, 711003, 711004, 711010, 711011, 711024, 711045, 711046, 711062, 711118, 711142, 711143, 711165, 711172, 711181, 711186, 711255, 711608, 711716, 711717, 711720, 711728, 711740, 711741, 711747, 711758, 711781, 711787, 711792, 711796, 711804, 711855, 711874, 711877, 711886, 711890, 711927, 711961, 712013, 712232, 712250, 712254, 712257, 712290, 712292, 712298, 712303, 712305, 712306, 712307, 712309, 712314, 712315, 712318, 712320, 712321, 712323, 712325, 712329, 712331, 712333, 712334, 712335, 712338, 712344, 712345, 712346, 712347, 712349, 712356, 712357, 712358, 712359, 712360, 712364, 712365, 712366, 712372, 712373, 712377, 712378, 712380, 712384, 712385, 712391, 712398, 712400, 712407, 712409, 712411, 712451, 712453, 712463, 712466, 712470, 712476, 712479, 712484, 712497, 712503, 712521, 712529, 712530, 712541, 712543, 712763, 712765, 712871, 712895, 712898, 712970, 713043, 713045, 713060, 713061, 713063, 713068, 713086, 713111, 713118, 713142, 713190, 713202, 713232, 713263, 713275, 713279, 713337, 713367, 713375, 713397, 713420, 713422, 713432, 713441, 713442, 713443, 713447, 713457, 713459, 713462, 713464, 713469, 713475, 713477, 713480, 713484, 713485, 713486, 713489, 713730, 713821, 713829, 713834, 713846, 713847, 713848, 713849, 713861, 713863, 713864, 713873, 713874, 713877, 713883, 713888, 713889, 713892, 713893, 713898, 713902, 713903, 713905, 713915, 713918, 713919, 713920, 713922, 713923, 713924, 713927, 713929, 713932, 713936, 713938, 713943, 713965, 713970, 713971, 713972, 713975, 713980, 713987, 713988, 713991, 713992, 714102, 714116, 714133, 714142, 714146, 714149, 714181, 714236, 714237, 714242, 714246, 714253, 714257, 714258, 714259, 714278, 714279, 714286, 714294, 714324, 714325, 714338, 714348, 714367, 714368, 714373, 714377, 714378, 714382, 714383, 714387, 714438, 714445, 714446, 714468, 714472, 714483, 714485, 714504, 714517, 714522, 714524, 714532, 714534, 714535, 714539, 714572, 714573, 714578, 714580, 714584, 714590, 714594, 714596, 714597, 714601, 714602, 714603, 714604, 714608, 714609, 714610, 714611, 714612, 714614, 714615, 714616, 714617, 714620, 714622, 714623, 714627, 714633, 714635, 714636, 714638, 714646, 714650, 714652, 714653, 714655, 714661, 714662, 714665, 714668, 714670, 714671, 714672, 714673, 714675, 714676, 714678, 714680, 714682, 714686, 714694, 714695, 714697, 714699, 714701, 714703, 714709, 714712, 714716, 714718, 714726, 714732, 714733, 714737, 714740, 714743, 714746, 714749, 714751, 714754, 714763, 714765, 714767, 714769, 714770, 714776, 714779, 714783, 714786, 714787, 714789, 714792, 714793, 714795, 714799, 714800, 714802, 714806, 714807, 714812, 714815, 714816, 714819, 714824, 714827, 714829, 714832, 714833, 714834, 714835, 714838, 714840, 714841, 714842, 714843, 714846, 714850, 714851, 714853, 714856, 714857, 714859, 714862, 714869, 714871, 714873, 714875, 714879, 714880, 714882, 714884, 714885, 714907, 715054, 715062, 715073, 715079, 715099, 715121, 715128, 715181, 715188, 715249, 715250, 715255, 715256, 715259, 715291, 715301, 715306, 715313, 715330, 715360, 715377, 715439, 715443, 715447, 715463, 715478, 715491, 715512, 715520, 715541, 715552, 715553, 715556, 715575, 715579, 715582, 715590, 715601, 715611, 715626, 715628, 715631, 715638, 715642, 715647, 715648, 715653, 715654, 715663, 715674, 715681, 715682, 715691, 715695, 715697, 715700, 715705, 715706, 715725, 715726, 715731, 715743, 715744, 715749, 715751, 715763, 715764, 715766, 715770, 715771, 715773, 715776, 715781, 715782, 715787, 715791, 715795, 715796, 715797, 715800, 715814, 715819, 715823, 715824, 715831, 715832, 715833, 715837, 715838, 715841, 715842, 715845, 715848, 715851, 715853, 715854, 715858, 715875, 715878, 715885, 715889, 716057, 716075, 716092, 716094, 716098, 716099, 716103, 716104, 716114, 716116, 716122, 716124, 716128, 716133, 716170, 716171, 716177, 716178, 716191, 716192, 716193, 716204, 716231, 716236, 716242, 716245, 716251, 716295, 716296, 716298, 716308, 716351, 716363, 716388, 716396, 716405, 716416, 716447, 716453, 716460, 716470, 716474, 716477, 716478, 716486, 716494, 716509, 716515, 716517, 716531, 716536, 716537, 716637, 716656, 716694, 716729, 716739, 716790, 716799, 716833, 717107, 717116, 717119, 717133, 717138, 717139, 717140, 717149, 717160, 717167, 717179, 717195, 717196, 717207, 717217, 717218, 717223, 717270, 717274, 717283, 717579, 717591, 717593, 717595, 717596, 717597, 717598, 717599, 717635, 717646, 717661, 717662, 717663, 717680, 717688, 717690, 717696, 717699, 717703, 717711, 717712, 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Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0090-2026

Related Recalls

Class I - Dangerous

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).

Aug 20, 2025 Implants & Prosthetics View Details →
Class I - Dangerous

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).

Aug 20, 2025 Implants & Prosthetics View Details →
Class I - Dangerous

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).

Aug 20, 2025 Other Medical Devices View Details →