Boston Scientific Corporation: ACCOLADE DR SL MRI (Model L311)

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: 90,931 units Lot/code info: GTIN 00802526558962, Serial Numbers: 200737, 202944, 203132, 203273, 203512, 203621, 203903, 204448, 204712, 204767, 204877, 204938, 205006, 205007, 205020, 205029, 205055, 205063, 205068, 205069, 205076, 205077, 205079, 205088, 205116, 205218, 205226, 205261, 205328, 205330, 205339, 205354, 205355, 205375, 205398, 205400, 205423, 205457, 205515, 205544, 205552, 205601, 205613, 205633, 205642, 205645, 205651, 205656, 205668, 205694, 205699, 205705, 205713, 205716, 205717, 205719, 205728, 205772, 205778, 205808, 205816, 205818, 205830, 205833, 205835, 205838, 205870, 205896, 205956, 205983, 205995, 206085, 206094, 206117, 206123, 206144, 206152, 206157, 206252, 206260, 206265, 206285, 206325, 206375, 206404, 206408, 206411, 206505, 207204, 207462, 207887, 208016, 208046, 208192, 208212, 208325, 208368, 208372, 208379, 208434, 208449, 208461, 208465, 208471, 208489, 208632, 208636, 208651, 208658, 208690, 208788, 208952, 209027, 209089, 209115, 209132, 209185, 209198, 209201, 209214, 209215, 209221, 209230, 209231, 209253, 209338, 209365, 209443, 209820, 209837, 209851, 209873, 209888, 209893, 209918, 209924, 209931, 209990, 210009, 210010, 210015, 210059, 210092, 210107, 210120, 210150, 210157, 210160, 210182, 210202, 210255, 210300, 210345, 210348, 210354, 210434, 210469, 210513, 210517, 210846, 214405, 214877, 216563, 217673, 217871, 217939, 218076, 219080, 219100, 219169, 219194, 219243, 219266, 219308, 219327, 219338, 219375, 219384, 219451, 219457, 219479, 219523, 219689,

UPC codes

00802526558962

Source

Official record: FDA (Device enforcement) ↗

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