Boston Scientific Corporation: Model Number L210 PROPONENT 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: 41009 units Lot/code info: GTIN 00802526559082, Serial Numbers: 100002, 100009, 100010, 100011, 100012, 100014, 100017, 100020, 100021, 100023, 100024, 100026, 100029, 100034, 100037, 100038, 100040, 100041, 100045, 100046, 100047, 100049, 100054, 100057, 100061, 100066, 100068, 100071, 100072, 100073, 100074, 100083, 100085, 100093, 100097, 100100, 100103, 100104, 100109, 100112, 100121, 100122, 100124, 100125, 100135, 100136, 100138, 100140, 100147, 100153, 100156, 100162, 100163, 100165, 100166, 100168, 100170, 100171, 100181, 100197, 100205, 100214, 100222, 100235, 100237, 100268, 100270, 100271, 100272, 100273, 100280, 100281, 100288, 100295, 100302, 100309, 100324, 100328, 100337, 100339, 100354, 100359, 100360, 100363, 100369, 100372, 100377, 100384, 100386, 100387, 100391, 100400, 100403, 100404, 100410, 100411, 100413, 100415, 100421, 100423, 100431, 100432, 100434, 100435, 100438, 100439, 100440, 100443, 100460, 100473, 100488, 100491, 100492, 100496, 100502, 100504, 100510, 100526, 100534, 100535, 100536, 100539, 100546, 100547, 100548, 100549, 100551, 100552, 100556, 100561, 100567, 100581, 100584, 100585, 100587, 100588, 100592, 100593, 100598, 100599, 100602, 100604, 100605, 100606, 100610, 100613, 100619, 100623, 100629, 100630, 100634, 100639, 100640, 100644, 100647, 100650, 100653, 100661, 100663, 100666, 100669, 100674, 100681, 100682, 100686, 100688, 100692, 100694, 100696, 100698, 100702, 100708, 100713, 100719, 100720, 100722, 100724, 100728, 100730, 100737, 100742, 100743, 100749,

UPC codes

00802526559082

Source

Official record: FDA (Device enforcement) ↗

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