Boston Scientific Corporation: Model Number L231, PROPONENT 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: 63,851 units Lot/code info: GTIN 00802526559143, Serial Numbers: 756161, 799038, 841168. GTIN 00802526576423, Serial Numbers: 532638, 880141, 973836. GTIN 00802526578052, Serial Numbers: 594082, 727921, 812172, 832267, 899037, 944246, 978524. GTIN 00802526559143, Serial Numbers: 100008, 100026, 100030, 100038, 100045, 100046, 100052, 100053, 100059, 100061, 100066, 100077, 100078, 100079, 100081, 100083, 100087, 100088, 100099, 100104, 100105, 100108, 100114, 100126, 100130, 100134, 100136, 100142, 100148, 100151, 100153, 100154, 100156, 100161, 100162, 100163, 100164, 100165, 100168, 100172, 100175, 100178, 100180, 100181, 100187, 100188, 100190, 100191, 100193, 100196, 100199, 100201, 100203, 100205, 100206, 100207, 100208, 100210, 100212, 100213, 100216, 100218, 100220, 100235, 100236, 100243, 100244, 100245, 100246, 100247, 100251, 100252, 100253, 100254, 100256, 100261, 100265, 100275, 100279, 100280, 100282, 100283, 100288, 100289, 100292, 100293, 100294, 100296, 100299, 100300, 100302, 100305, 100306, 100307, 100308, 100309, 100310, 100314, 100316, 100317, 100318, 100322, 100326, 100327, 100328, 100329, 100333, 100335, 100339, 100340, 100341, 100342, 100345, 100348, 100350, 100352, 100358, 100361, 100364, 100365, 100366, 100367, 100368, 100370, 100371, 100372, 100373, 100375, 100376, 100377, 100379, 100381, 100389, 100395, 100409, 100411, 100412, 100414, 100415, 100416, 100417, 100418, 100438, 100439, 100441, 100442, 100443, 100444, 100445, 100447, 100448, 100449, 100450, 100451, 100452, 100454,

UPC codes

00802526559143, 00802526576423, 00802526578052

Source

Official record: FDA (Device enforcement) ↗

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