Boston Scientific Corporation: Model Number L121 ESSENTIO DR EL 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: 10,833 units Lot/code info: GTIN 00802526559242, Serial Numbers: 100009, 100026, 100029, 100030, 100031, 100042, 100189, 100192, 100207, 100290, 100309, 100310, 100311, 100312, 100317, 100320, 100322, 100324, 100328, 100331, 100333, 100334, 100362, 100368, 100375, 100377, 100382, 100383, 100385, 100386, 100394, 100397, 100399, 100400, 100402, 100404, 100406, 100407, 100408, 100410, 100411, 100412, 100413, 100414, 100415, 100417, 100420, 100423, 100424, 100425, 100428, 100429, 100430, 100431, 100433, 100435, 100438, 100440, 100444, 100445, 100448, 100449, 100450, 100454, 100456, 100457, 100458, 100459, 100461, 100462, 100463, 100464, 100466, 100470, 100474, 100480, 100491, 100492, 100495, 100497, 100498, 100500, 100501, 100503, 100506, 100510, 100513, 100515, 100521, 100522, 100525, 100527, 100530, 100534, 100535, 100537, 100538, 100541, 100542, 100554, 100555, 100556, 100558, 100559, 100560, 100561, 100562, 100563, 100567, 100570, 100571, 100582, 100590, 100594, 100596, 100599, 100604, 100605, 100606, 100607, 100608, 100613, 100617, 100618, 100620, 100622, 100625, 100626, 100628, 100629, 100631, 100632, 100633, 100634, 100635, 100636, 100637, 100638, 100639, 100641, 100643, 100644, 100645, 100646, 100647, 100648, 100649, 100650, 100651, 100653, 100656, 100657, 100658, 100659, 100660, 100661, 100666, 100668, 100669, 100670, 100671, 100672, 100673, 100676, 100677, 100681, 100682, 100684, 100685, 100686, 100688, 100693, 100694, 100695, 100697, 100698, 100699, 100700, 100703, 100705, 100709, 100710, 100712,

UPC codes

00802526559242

Source

Official record: FDA (Device enforcement) ↗

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