Tandem Life LifeSPARC Controller (Cardiac Assist) – Software Failure (2022)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model 5900-0000; Controller Only Model 5900-0001. For circulatory or cardiopulmonary bypass.
Brand
Cardiac Assist, Inc
Lot Codes / Batch Numbers
C50232, C50253, C50403, C00195, C50619, C50623, C50161, C50167, C50388, C50432, C50505, C00189, C50437, C50671, C50690, C50362, C50648, C00048, C00087, C00149, C50274, C50506, C50308, C50319, C00040, C00107, C50160, C50016, C50604, C50493, C50355, C00126, C00155, C50113, C00041, C00135, C00042, C00035, C50012, C50019, C00176, C50386, C00052, C00076, C00092, C50490, C00095, C50149, C00182, C50392, C50337, C50451, C50306, C50460, C50512, C50082, C50092, C50174, C00151, C50328, C50349, C50111, C50501, C00157, C50363, C50353, C50476, C50212, C50219, C50350, C00174, C00006, C50076, C50105, C50235, C50613, C50197, C50375, C50463, C50517, C50632, C50662, C00199, C00205, C50699, C50269, C50398, C50618, C50645, C50100, C50101, C50626, C50204, C50266, C50330, C50031, C50050, C50241, C50524, C50181, C50365, C00038, C50237, C00190, C50598, C50005, C50213, C50214, C50283, C00143, C50287, C50288, C50259, C50285, C50270, C50639, C00158, C50357, C50601, C50289, C50059, C50065, C50043, C50037, C50072, C50096, C50153, C50140, C50703, C50391, C50536, C50682, C50314, C50354, C50470, C50409, C50526, C50146, C50225, C50226, C50001, C50090, C00169, C00023, C00161, C50224, C50230, C50254, C50458, C50525, C50581, C50591, C50378, C50428, C50466, C50539, C50303, C00063, C00071, C50211, C50229, C50280, C00167, C50374, C50387, C00141, C00136, C00145, C50312, C00073, C50243, C00150, C50222, C50343, C50425, C00053, C00057, C50652, C00113, C00114, C50038, C50247, C50651, C50521, C00072, C50485, C50492, C50057, C50126, C00152, C50530, C00086, C00094, C00181, C50389, C50399, C50453, C50169, C50148, C00148, C50456, C50015, C00098, C50465, C50448, C00179, C50406, C50026, C50044, C50162, C00016, C50056, C50170, C50042, C50058, C00039, C00078, C00093, C00089, C50157, C50234, C50236, C50318, C50395, C00166, C50327, C50356, C50410, C50471, C50262, C50385, C50195, C50196, C00132, C00130, C50381, C50436, C50435, C50047, C50055, C50064, C50429, C50370, C50377, C50486, C50627, C50664, C50066, C50078, C50468, C50093, C00129, C50186, C50338, C50483, C50216, C50077, C50108, C00180, C50414, C00079, C00172, C50248, C50257, C50592, C50640, C00083, C50041, C50364, C50452, C50074, C50479, C50575, C00201, C50046, C50326, C50498, C50430, C50438, C50607, C50018, C50175, C50014, C00144, C50477, C50418, C50267, C50119, C00128, C50024, C50185, C50256, C50290, C00165, C50400, C50508, C00015, C00044, C00045, C50344, C50631, C50649, C50635, C50182, C50198, C50251, C50503, C50084, C50122, C50130, C50115, C50228, C00184, C50507, C50087, C50532, C50188, C50104, C50531, C00051, C50051, C50123, C50294, C50444, C50600, C50271, C50272, C50296, C50313, C50279, C00138, C50194, C00054, C00081, C50376, C50624, C50630, C00171, C50434, C50457, C00175, C50599, C50263, C50497, C50496, C50494, C50322, C50411, C50107, C00146, C50089, C50473, C50176, C50307, C00194, C50171, C50459, C50616, C50636, C50647, C00085, C00137, C00139, C50298, C50348, C50215, C50351, C50667, C50663, C50641, C50120, C50109, C50537, C50145, C50514, C00109, C50035, C50010, C50080, C00046, C50393, C50397, C50446, C50462, C50644, C50657, C50656, C50439, C50449, C50334, C50052, C50062, C50190, C50300, C00163, C00164, C00043, C00082, C50033, C00156, C00080, C50070, C50003, C50004, C50020, C50191, C50187, C50405, C50422, C50511, C50116, C50184, C50143, C50154, C50060, C50063, C50299, C50379, C50488, C50331, C00183, C50136, C50139, C50177, C50141, C00178, C50582, C00088, C50025, C50193, C50495, C50007, C50110, C50164, C00168, C00050, C50221, C50489, C50596, C00206, C50685, C50584, C50673, C50324, C50345, C50382, C50320, C50472, C50474, C50183, C50205, C50323, C50440, C00192, C50629, C50579, C50646, C50661, C50589, C50321, C50424, C50192, C50220, C50252, C50402, C00066, C00101, C50481, C50029, C50217, C50233, C50467, C00049, C00062, C00200, C00204, C00068, C00034, C50255, C50342, C50309, C50361, C50006, C50048, C50036, C50068, C50401, C50333, C50081, C50049, C50103, C50346, C50347, C50519, C50152, C50297, C50369, C50373, C50189, C50292, C50316, C50528, C50620, C50246, C50242, C00056, C00077, C00160, C50595, C50594, C50311, C50304, C50121, C50454, C50239, C50273, C50282, C50416, C50621, C50504, C50441, C50587, C00154, C50227, C50368, C50478, C00170, C00173, C50339, C00153, C00159, C50264, C50396, C00055, C00105, C50284, C50605, C50132, C50583, C50231, C50240, C50461, C50352, C50383, C50527, C00112, C50028, C50013, C50159, C50455, C50295, C00074, C50201
Products Sold
Model 5900-0000 - UDI-DI: 00814112020562 Model 5900-0001 - UDI-DI: 00814112020623 Serial No.: C00115, C50232, C50253, C50403, C00195, C50619, C50623, C50161, C50167, C50388, C50432, C50505, C00189, C50437, C50671, C50690, C50362, C50648, C00048, C00087, C00149, C50274, C50506, C50308, C50319, C00040, C00107, C50160, C50016, C50604, C50493, C50355, C00126, C00155, C50113, C00041, C00135, C00042, C00035, C50012, C50019, C00176, C50386, C00052, C00076, C00092, C50490, C00095, C50149, C00182, C50392, C50337, C50451, C50306, C50460, C50512, C50082, C50092, C50174, C00151, C50328, C50349, C50111, C50501, C00157, C50363, C50353, C50476, C50212, C50219, C50350, C00174, C00006, C50076, C50105, C50235, C50613, C50197, C50375, C50463, C50517, C50632, C50662, C00199, C00205, C50699, C50269, C50398, C50618, C50645, C50100, C50101, C50626, C50204, C50266, C50330, C50031, C50050, C50241, C50524, C50181, C50365, C00038, C50237, C00190, C50598, C50005, C50213, C50214, C50283, C00143, C50287, C50288, C50259, C50285, C50270, C50639, C00158, C50357, C50601, C50289, C50059, C50065, C50043, C50037, C50072, C50096, C50153, C50140, C50703, C50391, C50536, C50682, C50314, C50354, C50470, C50409, C50526, C50146, C50225, C50226, C50001, C50090, C00169, C00023, C00161, C50224, C50230, C50254, C50458, C50525, C50581, C50591, C50378, C50428, C50466, C50539, C50303, C00063, C00071, C50211, C50229, C50280, C00167, C50374, C50387, C00141, C00136, C00145, C50312, C00073, C50243, C00150, C50222, C50343, C50425, C00053, C00057, C50652, C00113, C00114, C50038, C50247, C50651, C50521, C00072, C50485, C50492, C50057, C50126, C00152, C50530, C00086, C00094, C00181, C50389, C50399, C50453, C50169, C50148, C00148, C50456, C50015, C00098, C50465, C50448, C00179, C50406, C50026, C50044, C50162, C00016, C50056, C50170, C50042, C50058, C00039, C00078, C00093, C00089, C50157, C50234, C50236, C50318, C50395, C00166, C50327, C50356, C50410, C50471, C50262, C50385, C50195, C50196, C00132, C00130, C50381, C50436, C50435, C50047, C50055, C50064, C50429, C50370, C50377, C50486, C50627, C50664, C50066, C50078, C50468, C50093, C00129, C50186, C50338, C50483, C50216, C50077, C50108, C00180, C50414, C00079, C00172, C50248, C50257, C50592, C50640, C00083, C50041, C50364, C50452, C50074, C50479, C50575, C00201, C50046, C50326, C50498, C50430, C50438, C50607, C50018, C50175, C50014, C00144, C50477, C50418, C50267, C50119, C00128, C50024, C50185, C50256, C50290, C00165, C50400, C50508, C00015, C00044, C00045, C50344, C50631, C50649, C50635, C50182, C50198, C50251, C50503, C50084, C50122, C50130, C50115, C50228, C00184, C50507, C50087, C50532, C50188, C50104, C50531, C00051, C50051, C50123, C50294, C50444, C50600, C50271, C50272, C50296, C50313, C50279, C00138, C50194, C00054, C00081, C50376, C50624, C50630, C00171, C50434, C50457, C00175, C50599, C50263, C50497, C50496, C50494, C50322, C50411, C50107, C00146, C50089, C50473, C50176, C50307, C00194, C50171, C50459, C50616, C50636, C50647, C00085, C00137, C00139, C50298, C50348, C50215, C50351, C50667, C50663, C50641, C50120, C50109, C50537, C50145, C50514, C00109, C50035, C50010, C50080, C00046, C50393, C50397, C50446, C50462, C50644, C50657, C50656, C50439, C50449, C50334, C50052, C50062, C50190, C50300, C00163, C00164, C00043, C00082, C50033, C00156, C00080, C50070, C50003, C50004, C50020, C50191, C50187, C50405, C50422, C50511, C50116, C50184, C50143, C50154, C50060, C50063, C50299, C50379, C50488, C50331, C00183, C50136, C50139, C50177, C50141, C00178, C50582, C00088, C50025, C50193, C50495, C50007, C50110, C50164, C00168, C00050, C50221, C50489, C50596, C00206, C50685, C50584, C50673, C50324, C50345, C50382, C50320, C50472, C50474, C50183, C50205, C50323, C50440, C00192, C50629, C50579, C50646, C50661, C50589, C50321, C50424, C50192, C50220, C50252, C50402, C00066, C00101, C50481, C50029, C50217, C50233, C50467, C00049, C00062, C00200, C00204, C00068, C00034, C50255, C50342, C50309, C50361, C50006, C50048, C50036, C50068, C50401, C50333, C50081, C50049, C50103, C50346, C50347, C50519, C50152, C50297, C50369, C50373, C50189, C50292, C50316, C50528, C50620, C50246, C50242, C00056, C00077, C00160, C50595, C50594, C50311, C50304, C50121, C50454, C50239, C50273, C50282, C50416, C50621, C50504, C50441, C50587, C00154, C50227, C50368, C50478, C00170, C00173, C50339, C00153, C00159, C50264, C50396, C00055, C00105, C50284, C50605, C50132, C50583, C50231, C50240, C50461, C50352, C50383, C50527, C00112, C50028, C50013, C50159, C50455, C50295, C00074, C50201
Cardiac Assist, Inc is recalling TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model 5900-0000; Controller O due to Critical Failure of the LifeSPARC controller when the software freezes or crashes and the screen does not display data.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Critical Failure of the LifeSPARC controller when the software freezes or crashes and the screen does not display data.
Recommended Action
Per FDA guidance
On July 21, 2022, the recalling firm notified impacted customers through mailed letters. Customers were instructed to use Operations Manual revision 15 and to discard all previous revisions of the Operations Manuals.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026