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).
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). Distribution: Worldwide Quantity: 41,191 units Lot/code info: GTIN 00802526559471, Serial numbers: 726570, 728246, 728341, 728391, 728414, 728416, 728463, 728492, 728880, 732912, 733290, 733427, 733464, 733475, 733541, 733672, 733700, 733703, 733748, 733749, 733755, 733756, 733773, 733776, 733778, 733791, 733792, 733794, 733797, 733799, 733800, 733801, 733804, 733805, 733807, 733808, 733811, 733812, 733815, 733818, 733819, 733820, 733824, 733829, 733830, 733832, 733833, 733834, 733841, 733842, 733843, 733846, 733851, 733852, 733853, 733854, 733859, 733861, 733862, 733864, 733876, 733880, 733881, 733883, 733887, 733888, 733895, 733896, 733897, 733898, 733899, 733904, 733907, 733908, 733909, 733916, 733925, 733926, 733927, 733928, 733931, 733934, 733935, 733936, 733939, 733944, 733960, 733976, 733980, 733982, 734809, 734811, 734812, 734822, 734824, 734837, 734844, 734870, 734880, 734884, 734899, 734902, 734939, 734944, 734955, 734960, 734967, 734977, 734982, 734991, 734992, 734997, 734998, 734999, 735005, 735006, 735013, 735015, 735024, 735028, 735034, 735035, 735039, 735042, 735045, 735053, 735056, 735061, 735067, 735070, 735075, 735083, 735088, 735127, 735217, 735250, 735251, 735262, 735328, 735333, 735340, 735341, 735351, 735401, 735412, 735434, 735440, 735446, 735447, 735455, 735478, 735481, 735494, 735498, 735505, 735506, 735508, 735510, 735511, 735512, 735514, 735515, 735516, 735520, 735525, 735527, 735531, 735532, 735539, 735546, 735547, 735561, 735562, 735575, 735582, 735585, 735591, 735611, 735625, 735635, 735643, 735667, 735756,
00802526559471
Official record: FDA (Device enforcement) ↗
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