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: 12,326 units Lot/code info: GTIN 00802526559426, Serial numbers: 709683, 709711, 709737, 709778, 709780, 709789, 709792, 709794, 709804, 709815, 709816, 709827, 709828, 709829, 709830, 709831, 709889, 709907, 709912, 709914, 709926, 709935, 709938, 709941, 709943, 709962, 709965, 709966, 709969, 709985, 710005, 710016, 710027, 710105, 710235, 710283, 710379, 710386, 710408, 710414, 710416, 710418, 710424, 710438, 710443, 710450, 710458, 710459, 710466, 710467, 710479, 710481, 710482, 710490, 710540, 710544, 710545, 710558, 710561, 710566, 710571, 710572, 710575, 710586, 710593, 710595, 710600, 710613, 710622, 710624, 711100, 711103, 711115, 711116, 711186, 711234, 711261, 711493, 711497, 711646, 711698, 711699, 711704, 711706, 711719, 711756, 711771, 711780, 711781, 711783, 711784, 711812, 711817, 711852, 711859, 711865, 711867, 711870, 711881, 711894, 711896, 711901, 711913, 711915, 711916, 711927, 711929, 711933, 711941, 711977, 711984, 712029, 712100, 712114, 712120, 712122, 712140, 712143, 712187, 712188, 712192, 712194, 712196, 712197, 712205, 712211, 712269, 712275, 712302, 712361, 712362, 712368, 712394, 712395, 712446, 712452, 712454, 712467, 712468, 712472, 712475, 712485, 712487, 712518, 712562, 712570, 712605, 712647, 712660, 712665, 712668, 712669, 712676, 712684, 712716, 712730, 712732, 712734, 712740, 712743, 712749, 712763, 712791, 712837, 712843, 712908, 712936, 712971, 713013, 713125, 713135, 713155, 713157, 713158, 713161, 713176, 713179, 713184, 713185, 713199, 713201, 713206, 713212,
00802526559426, 00802526559433
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.