Boston Scientific Corporation: Model Number L111, ESSENTIO DR SL MRI 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: 223,163 units Lot/code info: GTIN 00802526559228, Serial numbers: 103410, 200337, 200359, 200704, 201273, 201585, 202131, 203086, 204240, 204255, 204383, 204472, 204532, 204553, 204558, 204581, 204619, 204644, 204658, 204672, 204680, 204704, 204729, 204735, 204748, 204768, 204779, 204855, 204883, 204891, 204907, 204916, 204929, 204934, 204947, 204951, 204957, 204959, 204968, 204985, 205002, 205044, 205073, 205083, 205105, 205130, 205149, 205192, 205199, 205211, 205227, 205233, 205236, 205290, 205360, 205362, 205363, 205408, 205412, 205413, 205415, 205455, 205480, 205543, 205553, 205560, 205585, 205586, 205587, 205625, 205632, 205636, 205672, 205673, 205686, 205688, 205733, 205742, 205767, 205770, 205773, 205782, 205791, 205796, 205797, 205810, 205854, 205855, 205857, 205861, 205863, 205907, 205911, 205920, 205940, 205945, 205946, 205958, 205961, 205965, 205967, 205971, 205975, 205977, 205979, 205989, 205992, 205997, 205998, 206011, 206019, 206033, 206045, 206046, 206049, 206069, 206070, 206074, 206075, 206080, 206090, 206091, 206092, 206095, 206098, 206112, 206115, 206122, 206129, 206138, 206140, 206142, 206146, 206167, 206175, 206184, 206190, 206192, 206195, 206200, 206217, 206219, 206220, 206222, 206225, 206226, 206230, 206233, 206244, 206255, 206263, 206277, 206287, 206294, 206295, 206297, 206299, 206300, 206318, 206320, 206326, 206333, 206342, 206343, 206346, 206373, 206407, 206412, 206415, 206437, 206458, 206473, 206502, 206509, 206533, 206541, 206548, 206551, 206556, 206578, 206699, 206762, 206855,

UPC codes

00802526559228

Source

Official record: FDA (Device enforcement) ↗

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