Boston Scientific Corporation: Model Number L100, ESSENTIO SR SL Pacemaker

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: 4827 units Lot/code info: GTIN 00802526559150, Serial Numbers: 464853, 464855, 464865, 464866, 464867, 464868, 464871, 464872, 464874, 464879, 464881, 464882, 464886, 464896, 464907, 464911, 464912, 464913, 464914, 464915, 464916, 464917, 464919, 464921, 464922, 464925, 464927, 464929, 464930, 464935, 464937, 464938, 464939, 464940, 464941, 464947, 464948, 464955, 464956, 464957, 464960, 464962, 464966, 464967, 464970, 464971, 464972, 464977, 464978, 464979, 464980, 464982, 464983, 464988, 464991, 464997, 464998, 464999, 465004, 465005, 465006, 465007, 465009, 465011, 465012, 465014, 465015, 465019, 465025, 465026, 465027, 465029, 465032, 465037, 465038, 465041, 465043, 465044, 465046, 465049, 465050, 465053, 465054, 465055, 465056, 465057, 465060, 465061, 465062, 465063, 465064, 465065, 465067, 465069, 465070, 465072, 465075, 465076, 465078, 465079, 465081, 465084, 465085, 465088, 465089, 465092, 465093, 465097, 465102, 465103, 465104, 465105, 465106, 465113, 465116, 465123, 465126, 465128, 465132, 465133, 465134, 465135, 465136, 465138, 465145, 465148, 465149, 465150, 465151, 465152, 465153, 465154, 465158, 465161, 465162, 465163, 465165, 465169, 465170, 465173, 465176, 465183, 465188, 465189, 465192, 465193, 465194, 465199, 465201, 465206, 465208, 465213, 465226, 465234, 465238, 465248, 465249, 465264, 465281, 465290, 465292, 465293, 465301, 465302, 465304, 465314, 465351, 465352, 465377, 465382, 465385, 465399, 465408, 465412, 465415, 465417, 465419, 465425, 465427, 465434, 465441, 465442, 465445,

UPC codes

00802526559150

Source

Official record: FDA (Device enforcement) ↗

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