Boston Scientific Corporation: Model Number L131, ESSENTIO DR EL 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: 190,088 units Lot/code info: GTIN 00802526559266, Serial Numbers: 102068, 102071, 102072, 102074, 102086, 102089, 102091, 102092, 102094, 102095, 102097, 102101, 102102, 102104, 102108, 102115, 102120, 102122, 102124, 102129, 102145, 102146, 102149, 102157, 102175, 102176, 102181, 102187, 102188, 102189, 102191, 102194, 102195, 102196, 102197, 102198, 102202, 102203, 102205, 102206, 102207, 102208, 102211, 102212, 102213, 102215, 102218, 102221, 102223, 102226, 102227, 102228, 102235, 102240, 102241, 102244, 102250, 102253, 102258, 102259, 102262, 102268, 102270, 102271, 102275, 102281, 102282, 102283, 102284, 102285, 102286, 102288, 102289, 102294, 102304, 102308, 102310, 102312, 102318, 102319, 102320, 102321, 102322, 102328, 102330, 102331, 102332, 102334, 102336, 102338, 102339, 102341, 102342, 102345, 102348, 102352, 102359, 102360, 102365, 102366, 102369, 102372, 102376, 102377, 102381, 102382, 102383, 102384, 102387, 102388, 102390, 102395, 102397, 102398, 102399, 102403, 102404, 102405, 102407, 102408, 102411, 102412, 102418, 102421, 102425, 102427, 102428, 102439, 102440, 102447, 102450, 102451, 102452, 102453, 102455, 102456, 102457, 102458, 102462, 102463, 102465, 102467, 102468, 102469, 102472, 102479, 102480, 102481, 102486, 102489, 102490, 102494, 102499, 102501, 102504, 102505, 102506, 102512, 102520, 102522, 102523, 102524, 102525, 102527, 102528, 102529, 102530, 102532, 102533, 102537, 102539, 102543, 102545, 102548, 102549, 102550, 102551, 102552, 102553, 102555, 102556, 102559, 102561,

UPC codes

00802526559266

Source

Official record: FDA (Device enforcement) ↗

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