Boston Scientific Corporation: ACCOLADE DR EL MRI (Model L331)

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: 34,180 units Lot/code info: GTIN 00802526559006, Serial Numbers: 102138, 102172, 102192, 102209, 102210, 102229, 102231, 102232, 102233, 102237, 102239, 102243, 102255, 102256, 102261, 102263, 102265, 102266, 102267, 102269, 102273, 102274, 102277, 102290, 102358, 102389, 102392, 102422, 102435, 102438, 102441, 102445, 102448, 102460, 102464, 102466, 102474, 102503, 102513, 102564, 102624, 102625, 110031, 110032, 110057, 110099, 110165, 110168, 110174, 110176, 110261, 110262, 110280, 110293, 110318, 110371, 110433, 110436, 110496, 110507, 110517, 110550, 110718, 110749, 110768, 110814, 110837, 110841, 110846, 110865, 110876, 110932, 110933, 110938, 110939, 110953, 110965, 110984, 110985, 110989, 111044, 111074, 111095, 111104, 111116, 111143, 111160, 111171, 111172, 111174, 111184, 111186, 111228, 111241, 111245, 111254, 111272, 111331, 111332, 111339, 111340, 111341, 111342, 111344, 111367, 111375, 111383, 111398, 111399, 111405, 111410, 111411, 111427, 111484, 111497, 111499, 111500, 111502, 111503, 111504, 111508, 111509, 111512, 111514, 111516, 111518, 111520, 111522, 111535, 111536, 111538, 111550, 111552, 111557, 111561, 111575, 111586, 111590, 111591, 111593, 111606, 111611, 111612, 111614, 111615, 111676, 111678, 111701, 111708, 112011, 112235, 112407, 112682, 112771, 112776, 112778, 112825, 112839, 112915, 112919, 113046, 113067, 113068, 113097, 113103, 113121, 113128, 113159, 113207, 113216, 113230, 113267, 113270, 113271, 113284, 113294, 113300, 113304, 113354, 113401, 113410, 113455, 113488,

UPC codes

00802526559006

Source

Official record: FDA (Device enforcement) ↗

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