Model Number S722, Altrua 2 DR EL Pacemaker recalled

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).

GTIN 00802526559372, Serial numbers: 100037, 100039, 100040, 100041, 100042, 100052, 100066, 100067, 100068, 100070, 100071, 100072, 100073, 100075, 100076, 100077, 100080, 100081, 700442, 700445, 700447, 700448, 700452, 700455, 700470, 700486, 700541, 700554, 700568, 700569, 700589, 700636, 700666, 702537, 702548, 702681, 702731, 702760, 702763, 702766, 702767, 702773, 702775, 702900, 702902, 702903, 702911, 702930, 704458, 704459, 704521, 707526, 707529, 708164, 708180, 708183, 708252, 708264, 708427. GTIN 00802526576515, Serial numbers: 100002, 100003, 100004, 100006, 100008, 100009, 100010, 100011, 100012, 100014, 100015, 100016, 100017, 100018, 100019, 100020, 100021, 100022, 100023, 100024, 100025, 100026, 100027, 100029, 100030, 100031, 100032, 100033, 100034, 100035, 100036, 100038, 100044, 100046, 100047, 100048, 100049, 100050, 100053, 100054, 100055, 100056, 100057, 100059, 100060, 100061, 100064, 100078, 100082, 100083, 100084, 100086, 100088, 100089, 100090, 100091, 100092, 100093, 100094, 100095, 100096, 700001, 700002, 700003, 700004, 700005, 700006, 700007, 700008, 700009, 700011, 700012, 700013, 700014, 700016, 700017, 700018, 700019, 700020, 700031, 700032, 700033, 700034, 700035, 700036, 700037, 700039, 700040, 700041, 700042, 700043, 700044, 700045, 700046, 700047, 700048, 700049, 700050, 700052, 700053, 700054, 700055, 700056, 700057, 700058, 700059, 700060, 700061, 700062, 700063, 700064, 700065, 700066, 700067, 700068, 700069, 700070, 700071, 700072, 700073, 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GTIN 00802526578113, Serial numbers: 700133, 700155, 700201, 700207, 700210, 700211, 700216, 700226, 700229, 700236, 700238, 700240, 700246, 700255, 700258, 700278, 700281, 700286, 700287, 700300, 700311, 700317, 700320, 700323, 700324, 700325, 700326, 700327, 700328, 700329, 700330, 700331, 700332, 700333, 700334, 700335, 700411, 700414, 700415, 700417, 700421, 700422, 700423, 700424, 700425, 700427, 700429, 700432, 700433, 700435, 700438, 700440, 700444, 700449, 700451, 700456, 700467, 700468, 700483, 700484, 700493, 700508, 700538, 700549, 700622, 700661, 700664, 700679, 700721, 700724, 700731, 700781, 700782, 700789, 700793, 700799, 700806, 700810, 700816, 700825, 700830, 700835, 700841, 700844, 700853, 700856, 700857, 700880, 701041, 701046, 701079, 701082, 701103, 701109, 701115, 701118, 701119, 701121, 701124, 701129, 701131, 701133, 701134, 701136, 701139, 701140, 701141, 701142, 701146, 701148, 701151, 701154, 701158, 701159, 701162, 701164, 701165, 701169, 701170, 701171, 701175, 701176, 701178, 701183, 701195, 701205, 701214, 701215, 701222, 701234, 701238, 701241, 701246, 701249, 701250, 701252, 701253, 701254, 701256, 701258, 701262, 701264, 701266, 701268, 701269, 701270, 701271, 701273, 701275, 701279, 701280, 701287, 701290, 701292, 701296, 701300, 701312, 701313, 701314, 701315, 701316, 701317, 701318, 701319, 701321, 701326, 701327, 701329, 701330, 701331, 701333, 701335, 701336, 701337, 701338, 701341, 701342, 701343, 701344, 701345, 701346, 701347, 701348, 701349, 701350, 701351, 701352, 701353, 701354, 701355, 701356, 701357, 701358, 701359, 701360, 701361, 701362, 701363, 701364, 701365, 701366, 701367, 701368, 701369, 701370, 701371, 701372, 701373, 701374, 701375, 701376, 701377, 701378, 701379, 701380, 701381, 701439, 701449, 701455, 701463, 701492, 701499, 701507, 701510, 701524, 701533, 701534, 701535, 701536, 701537, 701538, 701539, 701540, 701541, 701545, 701546, 701548, 701550, 701552, 701553, 701555, 701556, 701557, 701559, 701562, 701563, 701565, 701566, 701567, 701568, 701569, 701570, 701573, 701574, 701576, 701577, 701578, 701581, 701684, 701687, 701691, 701695, 701701, 701720, 701721, 701730, 701734, 701740, 701742, 701744, 701748, 701749, 701756, 701759, 701762, 701763, 701765, 701771, 701772, 701773, 701774, 701775, 701776, 701779, 701782, 701783, 701785, 701786, 701787, 701789, 701791, 701792, 701794, 701795, 701796, 701797, 701798, 701799, 701800, 701802, 701803, 701807, 701811, 701812, 701815, 701816, 701820, 701821, 701846, 701869, 701880, 702043, 702044, 702045, 702053, 702062, 702065, 702066, 702076, 702084, 702086, 702087, 702093, 702094, 702100, 702109, 702112, 702113, 702117, 702119, 702126, 702128, 702141, 702145, 702147, 702149, 702163, 702180, 702184, 702185, 702189.

Worldwide

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.