Boston Scientific Corporation: ACCOLADE SR SL (Model L300)

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).

Details from the source

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: 16,077 units Lot/code info: GTIN 00802526558900, Serial Numbers: 464190, 464192, 464197, 464228, 464229, 464230, 464238, 464258, 464279, 464295, 464296, 464316, 464321, 464358, 464360, 464361, 464362, 464363, 464369, 464371, 464378, 464383, 464384, 464392, 464393, 464398, 464400, 464406, 464408, 464409, 464410, 464411, 464414, 464425, 464427, 464430, 464432, 464435, 464437, 464441, 464442, 464443, 464451, 464455, 464456, 464466, 464469, 464474, 464480, 464484, 464485, 464487, 464488, 464489, 464496, 464502, 464503, 464504, 464507, 464520, 464529, 464531, 464534, 464538, 464544, 464547, 464551, 464556, 464558, 464560, 464566, 464571, 464577, 464583, 464585, 464586, 464587, 464588, 464591, 464592, 464604, 464608, 464611, 464617, 464623, 464635, 464637, 464639, 464642, 464643, 464653, 464660, 464662, 464664, 464665, 464667, 464668, 464681, 464683, 464685, 464692, 464697, 464698, 464699, 464700, 464706, 464707, 464708, 464712, 464715, 464720, 464721, 464726, 464730, 464734, 464736, 464738, 464740, 464741, 464743, 464744, 464745, 464746, 464749, 464750, 464751, 464754, 464758, 464761, 464766, 464767, 464771, 464772, 464774, 464775, 464776, 464778, 464779, 464781, 464784, 464787, 464788, 464795, 464796, 464797, 464800, 464805, 464806, 464807, 464810, 464811, 464821, 464824, 464825, 464828, 464830, 464831, 464833, 464837, 464838, 464843, 464848, 464852, 464857, 464858, 464859, 464860, 464870, 464883, 464891, 464893, 464899, 464900, 464901, 464902, 464926, 465020, 465058, 465118, 465121, 465147, 465171, 465179,

UPC codes

00802526558900, 00802526558917

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.